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Tundra lists 24 Oral Squamous Cell Carcinoma (OSCC) clinical trials. Each listing includes eligibility criteria, study locations, and direct links to research sites in the Tundra directory.
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NCT07906795
FENDRR and CRNDE With DUSP1 and DMBT1 in Oral Leukoplakia and Oral Squamous Cell Carcinoma
Oral squamous cell carcinoma (OSCC) is the most common cancer of the mouth and is often preceded by oral leukoplakia (OL), a white patch of the oral lining that can turn into cancer. At present it is difficult to predict which leukoplakias will become malignant, and OSCC is frequently diagnosed at a late stage. Long non-coding RNAs (lncRNAs) are RNA molecules that do not produce proteins but regulate genes and cell-signalling pathways, and they are being studied as markers of cancer. This prospective diagnostic and prognostic accuracy study examines whether two lncRNAs, FENDRR and CRNDE, and two proteins, DUSP1 and DMBT1, can distinguish OL and OSCC from normal oral tissue and from each other, and whether they predict the course of the disease. Their performance is compared with markers of the PI3K/AKT/mTOR and ERK signalling pathways (PI3K, AKT, mTOR, ERK2 and MMP9), which are commonly activated in oral cancer. Tissue is obtained from patients undergoing surgical removal of OL, OSCC, and from healthy volunteers undergoing routine minor gingival surgery (control group). No additional procedure is performed for the purpose of the study. The diagnosis and grade of each lesion are confirmed by two oral pathologists who are unaware of the laboratory results. FENDRR, CRNDE, PI3K, AKT and mTOR are measured by real-time RT-PCR, and DUSP1, DMBT1, ERK2 and MMP9 by ELISA. The primary outcome is the diagnostic accuracy (area under the ROC curve, sensitivity and specificity) of each marker for OL versus controls, OSCC versus controls and OSCC versus OL. Secondary outcomes are the association of marker expression with clinicopathological features (histological grade, clinical stage, degree of invasion, invasive front, lymph node and distant metastasis, and malignant transformation of OL) and with disease-free and overall survival during 24 months of follow-up. The study hypothesis is that low FENDRR, DUSP1 and DMBT1 and high CRNDE expression accompany progression from normal mucosa to OL and OSCC and are associated with a poorer outcome, so that these markers could support early diagnosis and risk assessment of oral potentially malignant and malignant lesions.
Gender: All
Updated: 2026-10-30
NCT07899255
Comparison of TLC (Total Leucocyte Count), Neutrophils and Monocytes in Oral Squamous Cell Carcinoma and Pre-malignant Disorders
Oral squamous cell carcinoma is one of the significant public health concerns and the most prevalent malignancies affecting the head and neck region globally. The primary risk factors for this cancer include tobacco usage, alcohol consumption and increasing incidence of human papillomavirus infections (HPV). The incidence of oral squamous carcinoma has been rising among young populations and the prognosis among young and older patients remains a debated issue. However, recent studies(1) found that there is no significant difference in tumor stage or grade based on age and the premalignant disorders represent an early stage in the evolution of cancer that characterized by molecular alterations and clonal expansions that progress to malignancy. This entails that age specifically is not a determining factor in aggressiveness and treatment outcomes of Oral squamous cell carcinoma, emphasizing the need to focus on other factors that influence prognosis of this condition(2). Premalignant disorders may involve detectable molecular alterations in blood cells and tissues, somatic mutations in key genes included DNMT3A and TET2 have been recognized in leukocytes of healthy individuals indicating a risk of future malignancy. There is a growing area of research where a comparison of hematological parameters like Total leukocytes Count (TLC), neutrophils and monocytes in OSCC patients versus those with premalignant disorders. The measurement of these blood markers provides an insight into immune response and systemic inflammation associated with malignancy progression. The evaluation and finding of Total leukocytes count, neutrophils and monocytes offered important and valuable prognostic information and also helped in distinguishing between malignant and premalignant conditions in the population. The monitoring of genetic mutations in blood cells of individuals could provide a non-invasive method to identify individuals at risk and help in better outcomes(3). The leukocyte counts particularly neutrophils, monocytes and total leukocytes count (TLC) have been investigated for cancer progression and patient immune response. Elevated levels of these blood cells have been observed in patients with oral squamous cell carcinoma indicating systemic inflammation and alterations in immune system that are associated with malignancy, whereas in premalignant conditions alterations in these parameters in the patients indicate immune response to cellular changes with key probable to predict malignant transformation. Comparing the levels of these blood counts in oral squamous cell carcinoma patients and those with premalignant lesions provide valuable awareness and insights into immunological, inflammatory processes involved in the early stages of cancer progression(4). There are approximately 3% of all the malignancies affecting around 270,000 people globally in annual rate. A significant amount of proportion of oral squamous cell carcinoma cases develops from premalignant disorders of the oral cavity including leukoplakia and oral submucous fibrosis, which has very high rate of malignant transformation(5). Therefore, hematological parameters would be explored as potential biomarkers for early detection of OSCC and its prognosis. Studies have revealed that quantitative changes in blood biochemistry and hematology occur during tumor initiation and progression, highlighting their potential role as the tumor markers(6). Therefore, despite the advancement of cancer therapy the prognosis of oral squamous cell carcinoma remained poor. This is largely due to the late diagnosis of the condition, however early detection is critical for improving patient outcomes and some recent research revealed various biomarkers and hematological parameters as a potential diagnostic tool and explored that immunological and hematological changes have been observed particularly alterations in total leukocyte count, neutrophils and monocytes and these changes have been investigated as an indicators of cancer progression. This underscores the importance of studying immune and also hematological detailed profiles in Oral squamous cell carcinoma and its precursor lesions(7). The purpose of the study is to assess and compare particular hematological parameters in individuals with premalignant conditions and those with squamous cell carcinoma. The study focus on hematological profile specifically Total leukocyte count (TLC), neutrophil count and monocyte count. By comparing these hematological markers in the patients with oral squamous cell carcinoma and the patients with pre-malignant lesions, therefore this study seeks to identify a distinct pattern that distinguishes between malignant and premalignant conditions. This comparative study aims to understand immune and inflammatory profiles of patients between two groups of study participants.
Gender: All
Ages: 18 Years - 70 Years
Updated: 2026-10-27
1 state
NCT07306546
Effectiveness of Hydrogen Water Intervention on Acute Oral Inflammation, Oral Microbiota, and Pain Following Free Flap Reconstruction in Patients With Oral Cancer
This randomized, double-blind, parallel-group controlled trial evaluates the effectiveness of hydrogen water oral care on acute oral inflammation, oral microbiota, and pain in patients with oral cancer who have undergone free flap reconstruction. After postoperative transfer from the intensive care unit to the plastic surgery ward, eligible patients who provide written informed consent are randomly assigned in a 1:1 ratio to receive oral care with either hydrogen water or boiled drinking water for 7 days. Saliva samples and pain assessments are collected at baseline (T0), Day 3 (T1), and Day 7 (T2) of the intervention.
Gender: All
Ages: 18 Years - Any
Updated: 2026-10-27
NCT07827872
Neoadjuvant Sintilimab Plus Chemotherapy for cT2N0M0 Oral Squamous Cell Carcinoma
This study is a superiority multi-center, open-label, phase III randomized controlled trial. It will further verify the clinical value of xidili single-antibody combined with chemotherapy (albumin paclitaxel and carboplatin) in neoadjuvant treatment for operable cT2N0M0 early oral squamous cell carcinoma (Oral Squamous Cell Carcinoma, OSCC) patients in terms of improving long-term survival and pathological remission. The study subjects are patients aged 18-75 years, diagnosed with cT2N0M0 stage (8th edition AJCC staging as stage II) OSCC by pathology, with ECOG score of 0-1, good organ function, and meeting laboratory standards (ANC ≥ 1.5 × 10⁹/L, Hb \> 90g/L, CrCl ≥ 60ml/min, ALT/AST ≤ 2.5 × ULN); Exclusion criteria include previous immunotherapy with immune checkpoint inhibitors, active autoimmune diseases, poorly controlled comorbidities, high viral load infection of HBV/HCV, etc.; Patients with surgical resection conditions and signing informed consent will be enrolled. The subjects were randomly divided into two groups at a ratio of 1:1: The experimental group received neoadjuvant treatment with xidili single-antibody combined with albumin paclitaxel and carboplatin for 2-3 cycles followed by surgery (primary lesion resection + I-III region cervical lymph node dissection), while the control group received standard treatment (direct surgery). The primary endpoint of the study is the 3-year event-free survival rate (Event-Free Survival rate, EFS rate), and secondary endpoints include overall survival rate (Overall survival rate, OS rate), major pathological response rate (Major Pathological Response, MPR), complete pathological response rate (Complete Pathological Response, pCR), objective response rate (Objective Response Rate, ORR), safety analysis (Treatment-Related Adverse Event, TRAE), and postoperative lymph node positive rate (Lymph Node Positivity rate, LNP rate). The sample size was calculated based on the Log-rank test, referring to the prospective clinical baseline data of standard surgical treatment for early oral cancer, setting the 3-year EFS rate of the control group at 80%, assuming that the experimental group can be improved to 90% (HR = 0.47), setting a two-sided α = 0.05, efficacy 80%, and follow-up dropout rate 10%, a total of 300 patients (150 in each group) need to be enrolled. This study will provide high-quality evidence-based evidence for optimizing the treatment strategy for cT2N0M0 early high-risk oral squamous cell carcinoma, improving the pathological response rate and long-term recurrence-free survival.
Gender: All
Ages: 18 Years - 75 Years
Updated: 2026-09-18
1 state
NCT07812467
Rimegepant-Sensitized Neoadjuvant Chemoimmunotherapy for Oral or Oropharyngeal Squamous Cell Carcinoma
This study will evaluate whether adding rimegepant to standard neoadjuvant chemoimmunotherapy can improve treatment response in patients with primary or recurrent oral or oropharyngeal squamous cell carcinoma who are planned to undergo surgery. Rimegepant blocks the receptor for calcitonin gene-related peptide, also known as CGRP. CGRP signaling may affect the tumor immune environment and the response of tumors to anticancer treatment. The study includes an initial safety run-in stage involving 20 participants, followed by a randomized controlled stage involving 200 participants. During the randomized stage, participants will be assigned in a 1:1 ratio to receive standard neoadjuvant chemoimmunotherapy either with or without rimegepant. All participants will receive two cycles of neoadjuvant treatment followed by definitive or intended curative surgery. The main outcome is the major pathological response rate, defined as 10% or less residual viable tumor in the surgical specimen. Other outcomes include pathological complete response, objective response, event-free survival, overall survival, changes in pain and quality of life, and treatment safety.
Gender: All
Ages: 18 Years - 75 Years
Updated: 2026-09-10
1 state
NCT07794813
Trop2-targeting NIR-II Molecular Probe for Precision Diagnosis of Oral Cancer
Given the morphological and clinical similarities between certain oral malignant neoplasms and benign conditions such as oral ulcerations or inflammatory lesions, the potential for misdiagnosis is significant. Currently, histopathological examination via tissue biopsy remains the diagnostic gold standard; however, this approach is inherently invasive and may yield incomplete diagnostic results due to sampling limitations and spatial heterogeneity of the lesion. These challenges underscore the urgent need for the development of simple, non-invasive, cost-effective, and real-time in vivo imaging modalities. To address this, the investigators propose the utilization of a previously developed near-infrared II (NIR-II) fluorescent molecular imaging probe, TTP-ICG, which exhibits high specificity for TROP2, a transmembrane glycoprotein frequently overexpressed in oral squamous cell carcinoma (OSCC). This study will evaluate the diagnostic accuracy of OSCC through localized application of the TROP2-targeted probe via clinical specimens being soaked in TTP-ICG solution. Furthermore, the investigators aim to explore the feasibility of employing a mouth wash-based delivery system for the probe, with the ultimate goal of establishing a precise, minimally invasive, and cost-effective real-time imaging strategy for the early detection and diagnosis of OSCC. Such an approach has the potential to significantly enhance diagnostic precision, improve patient outcomes, and increase survival rates.
Gender: All
Ages: 18 Years - 75 Years
Updated: 2026-08-31
1 state
NCT07778615
Immunohistochemical Expression of Cyclin D1 in Oral Squamous Cell Carcinoma: Relationship With Clinicodemographic and Histopathological Features
Oral squamous cell carcinoma is a major public health problem , especially in West Asian countries. Cyclin D1 accelerates cell cycle and thus may be implicated in uncontrolled cellular proliferation and tumor progression.
Gender: All
Updated: 2026-08-21
NCT07778368
A Multicenter, Prospective, Phase II Study of TROP-2 ADC in Combination With Toripalimab for Resectable Locally Advanced Oral Squamous Cell Carcinoma
This study is a multicenter, prospective, single-arm Phase II clinical trial evaluating the efficacy and safety of neoadjuvant therapy with TROP-2 ADC in combination with toripalimab for resectable locally advanced oral squamous cell carcinoma, followed by curative surgery and postoperative adjuvant radiotherapy or chemoradiotherapy.
Gender: All
Ages: 18 Years - 75 Years
Updated: 2026-08-21
NCT07745803
Discovery and Validation of Biomarkers for Periodontitis, Dental Caries and Oral Squamous Cell Carcinoma
The goal of this observational study is to develop better ways to detect and predict major oral diseases, including oral cancer, gum disease, and tooth decay. This study will collect detailed oral health information and biological samples from adults with different oral health conditions and healthy participants to identify markers that may help doctors detect diseases earlier and predict how diseases may change over time. The main questions this study aims to answer are whether biological markers from saliva, mouth rinse samples, blood, or oral tissue samples can help identify people with oral diseases, whether these markers can predict future disease changes such as worsening gum disease, new or progressing tooth decay, or recurrence and spread of oral cancer, and whether combining clinical information with biological markers can improve disease detection and risk prediction. Participants will receive a standard oral health examination, provide information about their health history and oral health behaviors, provide biological samples when appropriate, and be followed over time through clinical visits, questionnaires, and health information collection. Researchers will compare findings among people with different oral health conditions and healthy participants to better understand disease-related changes and develop tools for earlier detection and prediction of oral disease outcomes.
Gender: All
Ages: 18 Years - Any
Updated: 2026-08-04
1 state
NCT03085147
A Dye for the Detection of Cancer of the Tongue and Mouth
The purpose of this study is to test if an investigational dye, called PARPi-FL, can be used to detect this type of cancer. This will be the first time that PARPi-FL is being tried in people. First, the investigators will test the safety of PARPi-FL at different doses to find out what effects, if any, it has on people. The investigators will also see which amount of PARPi-FL is best suited to detect cancers of the mouth and tongue.
Gender: All
Ages: 18 Years - Any
Updated: 2026-08-04
2 states
NCT07726199
Study Comparing Different Neck Treatment Approaches in Patients With Oral Cancer Without Visible Neck Spread
The goal of this clinical trial is to learn whether selective neck dissection involving lymph node levels I-III is as effective as selective neck dissection involving levels I-IV in treating adults with clinically node-negative (cN0) oral squamous cell carcinoma undergoing curative surgery. It will also evaluate whether extending the neck dissection to level IV affects cancer control, surgical complications, shoulder function, and quality of life. The main questions it aims to answer are: * Does selective neck dissection of levels I-III provide regional recurrence-free survival comparable to selective neck dissection of levels I-IV? * Does extending the neck dissection to level IV improve overall survival, disease-free survival, or reduce regional recurrence? * Does selective neck dissection of levels I-III result in less postoperative morbidity, better shoulder function, and improved quality of life compared with selective neck dissection of levels I-IV? Researchers will compare patients undergoing selective neck dissection of levels I-III with those undergoing selective neck dissection of levels I-IV to determine whether routine removal of level IV lymph nodes provides additional oncological benefit while maintaining acceptable functional outcomes. Participants will: * Undergo surgery for oral squamous cell carcinoma with random assignment to selective neck dissection of either levels I-III or levels I-IV. * Receive standard postoperative treatment, including radiotherapy or chemoradiotherapy when indicated according to the final pathology report. * Attend scheduled follow-up visits for clinical examinations and surveillance for cancer recurrence. * Undergo assessments of shoulder function, sensory function, postoperative complications, and quality of life using validated questionnaires at predefined follow-up intervals.
Gender: All
Ages: 21 Years - 75 Years
Updated: 2026-08-04
1 state
NCT07692360
Salivary IL-6 and Interleukin Gene Polymorphisms in Oral Squamous Cell Carcinoma
This observational study will evaluate whether salivary interleukin-6 levels and selected interleukin gene polymorphisms are associated with regional lymph node involvement in patients with oral squamous cell carcinoma. Adult patients with histologically confirmed oral squamous cell carcinoma will be enrolled before receiving any cancer-specific treatment. Participants will be classified into two groups according to the presence or absence of regional lymph node metastasis: OSCC N0M0 and OSCC N+M0. The study does not involve any experimental treatment and does not change the standard diagnostic or therapeutic pathway. Each participant will provide a saliva sample using a sterile absorbent swab. The saliva sample will be used to measure interleukin-6 levels. Available biological material will also be used to analyze selected interleukin gene polymorphisms, including IL6, IL1B, IL10, IL8/CXCL8, and IL1RN. The aim of the study is to explore whether these salivary and genetic markers may help characterize different biological patterns of locoregional progression in oral squamous cell carcinoma.
Gender: All
Ages: 18 Years - Any
Updated: 2026-07-09
1 state
NCT07606638
Effectiveness of Opioid vs Pregabalin Plus Naproxen Sodium in Pain Management of Oral Cancer Patients
This randomized clinical study was designed to compare two pain treatment approaches for adults with oral cancer who had moderate to severe pain. Oral cancer pain may occur because of tumor growth, local tissue damage, inflammation, ulceration, or nerve involvement. Standard pain treatment often includes opioid medicines, but these medicines may cause side effects such as sedation, nausea, constipation, dizziness, tolerance, or dependence. In some patients, pain may also have a nerve-related or inflammatory component, where medicines such as pregabalin and naproxen sodium may provide additional benefit. A total of 98 eligible adult patients with histopathology-confirmed oral cancer and a baseline Visual Analog Scale pain score of 4 or more were included. Patients were randomly assigned into two treatment groups. One group received oral tramadol 50 mg every 4 hours, with dose adjustment according to pain relief and tolerability. The other group received oral pregabalin 75 mg twice daily with naproxen sodium 550 mg twice daily. Both treatments were given for 7 days under clinical monitoring. Pain intensity was measured using the Visual Analog Scale at baseline, day 3, and day 7. The main outcome was the mean reduction in pain score from baseline to day 7. Effective pain relief was defined as at least 50% reduction in the baseline pain score after 7 days of treatment. Side effects such as sedation, nausea or vomiting, constipation, dizziness, and gastrointestinal discomfort were also recorded. Patient satisfaction with pain control was assessed at the end of treatment.
Gender: All
Ages: 18 Years - Any
Updated: 2026-05-26
1 state
NCT07514767
Evaluation of the Efficacy and Safety of Nivolumab Neoadjuvant Treatment of Patients With Locally Advanced Oral Squamous Cell Carcinoma
This is a Phase II, single-centre, non-randomized, single-arm clinical trial to investigate the efficacy and safety of neoadjuvant nivolumab therapy in adult participants with resectable, locoregionally advanced Oral Squamous Cell Carcinoma (OSCC) tumors. Identification of predictive molecular biomarkers of tumor response to treatment will also be performed.
Gender: All
Ages: 18 Years - Any
Updated: 2026-04-07
NCT07371611
Sintilimab Plus Chemotherapy as Neoadjuvant and Adjuvant Treatment for Locally Advanced Oral Squamous Cell Carcinoma
This is a multicenter, open-label, randomized phase III clinical trial evaluating perioperative treatment with sintilimab combined with chemotherapy in patients with locally advanced oral squamous cell carcinoma. Despite standard treatment with surgery followed by postoperative radiotherapy or chemoradiotherapy, patients with locally advanced oral squamous cell carcinoma remain at high risk of recurrence or metastasis. Recent evidence, including results from the KEYNOTE-689 study, suggests that perioperative immunotherapy may improve survival outcomes, and this approach has been incorporated into NCCN guidelines. Combining immunotherapy with chemotherapy may further improve prognosis in this patient population. Eligible participants will be randomly assigned to either an experimental group or a control group. The experimental group will receive neoadjuvant sintilimab combined with chemotherapy followed by surgery and postoperative treatment based on pathological response. Patients with major pathological response (MPR) will receive adjuvant sintilimab, while patients without MPR will receive postoperative radiotherapy or concurrent chemoradiotherapy combined with sintilimab. The control group will receive standard treatment consisting of surgery followed by postoperative radiotherapy or chemoradiotherapy as clinically indicated. The primary objective of the study is to compare event-free survival between the two groups. Secondary objectives include overall survival, pathological response, safety, and treatment-related adverse events. The results of this study may help optimize perioperative treatment strategies and improve outcomes for patients with locally advanced oral squamous cell carcinoma.
Gender: All
Ages: 18 Years - 75 Years
Updated: 2026-01-28
1 state
NCT07137858
Adebrelimab Combined With Carboplatin and Albumin-bound Taxanol in the Treatment of Resectable Locally Advanced Oral Squamous Cell Carcinoma Cardiac, Randomized, Phase II Exploratory Study
Neoadjuvant immunochemotherapy can effectively increase the postoperative pathological complete response rate, improve the survival rate of patients, and reduce the risk of recurrence in oral squamous cell carcinoma (OSCC). Programmed death ligand-1 (PD-L1) plays a role in inhibiting the cancer-immune cycle by binding to negative regulatory factors of T cell activation such as PD-1 and B7.1. It has achieved good therapeutic effects in lung cancer, liver cancer and other cancers. Previous studies have shown that three cycles of PD-L1 inhibitors combined with chemotherapy have satisfactory efficacy and safety in locally advanced oral squamous cell carcinoma. However, during the three-cycle treatment process, due to the accumulation of drug toxicity, patients' tolerance to adverse reactions decreases, increasing the risk of serious adverse events and psychological pressure on patients. Based on this, this study aims to explore the efficacy of two cycles of avelumab (PD-L1 inhibitor) combined with chemotherapy in locally advanced oral squamous cell carcinoma, to explore whether it can achieve the same efficacy as three cycles while shortening the treatment time, reduce the risk of serious adverse events, and further verify the efficacy and safety of PD-L1 inhibitors combined with chemotherapy in the treatment of locally advanced oral squamous cell carcinoma. This study uses the postoperative pathological complete response (PCR) rate as the primary outcome indicator, and the objective response rate (ORR), major pathological response (MPR) rate, 2-year disease-free survival (EFS) rate, and 2-year and 5-year overall survival (OS) rate as secondary outcome indicators to evaluate the efficacy and long-term survival impact.
Gender: All
Ages: 18 Years - 75 Years
Updated: 2025-08-22
NCT07133958
A Bidirectional Observational Clinical Study of NAIC in the Treatment of Tumor Regression Patterns in LA-OSCC and LA-OPSCC
A prospective collection of 35 cases was conducted at Zhujiang Hospital of Southern Medical University. Patients diagnosed with locally advanced oral squamous cell carcinoma (LA-OSCC) or locally advanced oropharyngeal squamous cell carcinoma (LA-OPSCC) from April 2023 onward, who received two cycles of neoadjuvant immunochemotherapy (tislelizumab + paclitaxel + cisplatin/carboplatin) at our institution, were included. The study analyzed treatment safety, efficacy, tumor regression patterns, 2-year progression-free survival (PFS), and 5-year overall survival (OS) rates.
Gender: All
Ages: 18 Years - 80 Years
Updated: 2025-08-21
1 state
NCT07079410
Neoadjuvant and Adjuvant Sintilimab Plus Cetuximab in Locally Advanced Oral and Oropharyngeal Squamous Cell Carcinoma
The purpose of this study is to evaluate the effectiveness and safety of the combination therapy of immunotherapy (Sintilimab) with targeted therapy (Cetuximab) as a possible treatment before and after surgery for locally advanced oral/pharyngeal squamous cell carcinoma.
Gender: All
Ages: 18 Years - 75 Years
Updated: 2025-07-23
1 state
NCT05774483
Sentinel Node Biopsy Versus Limited Elective Neck Dissection in Early Cancers of Oral Cavity NoDe Negative
The goal of this clinical trial is to compare the survival outcomes, morbidity and cost-effectiveness of sentinel node biopsy versus limited elective neck dissection in node-negative early oral cancers. The main questions it aims to answer are: * Survival outcomes * Morbidity outcomes * Cost-effectiveness Participants will either undergo sentinel node biopsy followed by completion neck dissection if sentinel node is reported to be metastatic (SNB) or limited elective neck dissection where level IIb will be cleared only if level IIa is metastatic (limited END). The study will compare the outcomes in the two cohorts.
Gender: All
Ages: 18 Years - 80 Years
Updated: 2025-07-17
2 states
NCT07028918
A Prospective Single-Arm Study(NCLDR)
To investigate the safety and efficacy of low-dose radiotherapy combined with chemotherapy and immunotherapy as neoadjuvant therapy for locally advanced oral squamous cell carcinoma (OSCC), and to explore whether low-dose radiotherapy can induce cross-presentation of tumor-specific antigens, enhance lymphocyte infiltration into the tumor microenvironment, and thereby amplify tumor-specific immune responses, ultimately improving the therapeutic outcomes of neoadjuvant chemoimmunotherapy.
Gender: All
Ages: 18 Years - 70 Years
Updated: 2025-06-19
NCT06861712
Chemoimmunotherapy With or Without SBRT Before Surgery for Locally Advanced Oral and Oropharyngeal Cancer
In this study, participants will be randomly assigned to either the experimental group or the control group. The experimental group will first receive SBRT (6Gy\*3 fractions) to treat the primary tumor and metastatic lymph nodes. This will be followed by a combination of Toripalimab, Docetaxel, and Cisplatin for three cycles, every three weeks. The control group will receive the same combination of Toripalimab, Docetaxel, and Cisplatin for three cycles, every three weeks, but without SBRT. After the final round of chemotherapy, all participants will have imaging scans and, three weeks later, undergo surgery. After surgery, they may also receive additional radiotherapy with or without chemotherapy. Patients can also choose whether to continue treatment with Toripalimab after surgery.
Gender: All
Ages: 18 Years - 65 Years
Updated: 2025-04-25
1 state
NCT06728618
Preoperative Tislelizumab -Cetuximab - Chemotherapy Followed by Salvage Surgery and Adjuvant Tislelizumab -Cetuximab for Resectable, Locally Recurrent Oral and Oropharyngeal Squamous Cell Carcinoma
The purpose of this study is to evaluate the effectiveness and safety of the combination therapy of immunotherapy (Tislelizumab), targeted therapy (Cetuximab), with chemotherapy (Cisplatin and Nab-paclitaxel) as a possible treatment before and after salvage surgery for locally recurrent oral/pharyngeal squamous cell carcinoma. The combination of Tislelizumab,Cetuximab, Cisplatin and Nab-paclitaxel will be given prior to your surgery, while Tislelizumab and Cetuximab will be continued for approximately half a year after surgery.
Gender: All
Ages: 18 Years - 75 Years
Updated: 2024-12-11
1 state
NCT06726512
Quantitative Margin Assessment Using High-resolution Positron Emission Tomography - Computed Tomograhy
The primary endpoint is the assessment of the clinical value of a novel high-resolution mobile PET-CT scanner for intraoperative margin assessment in oral squamous cell carcinoma, soft tissue sarcoma and osteosarcoma surgery. The predicted margin status will be correlated with the margin status determined with histopathology.
Gender: All
Ages: 18 Years - Any
Updated: 2024-12-10
NCT06599801
Clinical Outcomes of Thoracodorsal Artery Flap in Oral and Maxillofacial Reconstruction
The goal of this study is to retrospectively compare different types of free flaps to determine the most suitable free flap for functional reconstruction in oral squamous cell carcinoma patients following tumor resection. The main questions it aims to answer are: Do the clinical characteristics of the thoracodorsal artery perforator flap differ from those of other types of flaps? Does the thoracodorsal artery perforator flap result in better clinical outcomes compared to other types of flaps? After reconstruction with the thoracodorsal artery perforator flap, do patients have better quality of life, speech function and scar healing compared to other types of flaps? Investigators will retrospectively compare the thoracodorsal artery perforator flap with other types of flaps (such as the anterolateral thigh flap, forearm flap, latissimus dorsi flap and fibula flap) to explore the most suitable free flap for facial defect reconstruction in oral squamous cell carcinoma patients. Participants are oral squamous cell carcinoma patients who previously underwent facial defect reconstruction with different types of flaps. Participants have completed relevant questionnaires at 1, 3, 6 and 12 months post-surgery. The data will be scored and assessed by the investigators.
Gender: All
Ages: 18 Years - Any
Updated: 2024-09-19
1 state