Clinical Research Directory

Efficacy and Safety of AK104 Combined With Chemotherapy for Neoadjuvant Treatment of Advanced Ovarian Cancer

This is a randomized, controlled, multicenter clinical study to evaluate AK104 in FIGO 2018 stage III-IV ovarian cancer subjects who were assessed to be at high perioperative risk and/or unable to achieve R0 resection prior to initial treatment. The efficacy and safety of neoadjuvant therapy with intravenous infusion combined with chemotherapy compared with chemotherapy alone.

Gait Parameters in Breast Cancer Receiving Chemotherapy Patients

Breast cancer is considered the most common type of malignancies, it is the most frequently diagnosed representing around 2.3 million cases. Where, their chemotherapy may cause fatigue affecting the overall quality of patient's life. Gait and balance are fundamental for activities of daily living and maintaining functional independence.

Antibody-Drug Conjugate Plus Immunotherapy Versus Immunotherapy Plus Chemotherapy for Extensive Transurethrally Unresectable Very-High-Risk Non-Muscle-Invasive Bladder Cancer

This randomized controlled trial aims to evaluate the efficacy and safety of antibody-drug conjugate (ADC) plus immunotherapy compared with immunotherapy plus chemotherapy in patients with extensive transurethrally unresectable very-high-risk non-muscle-invasive bladder cancer (NMIBC). Patients will be randomly assigned to receive either ADC plus immunotherapy or immunotherapy plus chemotherapy. The study will assess the effectiveness of these two treatment strategies in achieving complete response, maintaining disease control, and preserving the bladder, as well as their safety and tolerability. The findings may help identify an effective bladder-preserving treatment strategy for patients with extensive very-high-risk NMIBC who cannot undergo complete transurethral resection.

FRAIL and FiND for Chemotherapy Toxicity in GI Cancer

Older adults with gastrointestinal cancer may experience serious side effects during chemotherapy, particularly when they have reduced physical strength, functional limitations, or other health conditions. Identifying patients at greater risk before treatment begins may help clinicians plan appropriate monitoring and supportive care. The FRAIL-GI study is an observational study evaluating two brief screening tools, the FRAIL scale and the Frail Non-Disabled (FiND) questionnaire, in adults aged 65 years or older receiving adjuvant chemotherapy for nonmetastatic gastrointestinal cancer. Both tools assess aspects of frailty and physical vulnerability, but they classify patients differently. The FRAIL scale evaluates fatigue, resistance, walking ability, illnesses, and weight loss. The FiND questionnaire assesses frailty-related symptoms while distinguishing patients with mobility disability from those without mobility disability. The main objective is to investigate whether frailty assessments performed before chemotherapy are associated with severe treatment-related side effects during the following 180 days. Severe toxicity is defined as a grade 3 or higher adverse event according to the Common Terminology Criteria for Adverse Events, version 5.0. The study also evaluates whether adding FRAIL or FiND information to routine clinical factors improves the identification of patients at increased risk of severe chemotherapy toxicity. Additional assessments examine treatment modifications, unplanned hospitalizations, and the availability of follow-up evaluations. All chemotherapy regimens and supportive treatments are determined by the treating oncology team according to routine clinical practice. Participation does not involve assignment to an experimental treatment.

Tumor Microenvironment in Gastric Cancer Patients Treated With Combined Immunotherapy and Chemotherapy

The goal of this study is to analyze the tumor microenvironment (TME) in gastric cancer patients treated with combined immunotherapy and chemotherapy. The main questions it aims to answer are: * Provide profiles of TME between pre-treatment and post-treatment to gain insights into the mechanisms of immunotherapy combined with chemotherapy in advanced gastric cancer * Investigate the crucial factors affecting treatment efficacy by comparing gastric cancer patients with varying treatment responses

Biomarkers in Multiple Myeloma

The association between multiple myeloma (MM) and venous thromboembolism (VTE) is well known. Indeed, the incidence of VTE is increased in patients with newly diagnosed MM and in patients treated by immunomodulatory drugs in combination with glucocorticoids. Moreover, the clinical outcome of MM is supposed to be correlated to the risk of thrombosis. At the biological level, a number of hemostasis abnormalities participate in increasing VTE incidence. Yet, data on predictive biomarkers linked to VTE are limited.

A Prospective, Biomarker-Stratified Phase 2 Study: β-Hydroxybutyrate as a Predictive Biomarker for Short-Course Radiotherapy Followed by Chemotherapy Plus PD-1 Inhibitor Versus Chemotherapy Alone in Locally Advanced Rectal Cancer

This is a prospective, single-arm, biomarker-stratified, multicenter phase 2 clinical trial. All enrolled patients first receive short-course radiotherapy (SCRT), followed by measurement of serum β-hydroxybutyrate (β-HB) levels to calculate the post-radiotherapy elevation rate. Patients are stratified into an β-HB-positive stratum (elevation significantly) and an β-HB-negative stratum (no elevation), then randomized 1:1 within each stratum to receive either perioperative chemotherapy plus PD-1 inhibitor or perioperative chemotherapy alone. The primary endpoint is the complete response (CR) rate, defined as the composite of pathological complete response (pCR) and clinical complete response (cCR). The study aims to evaluate the efficacy and safety of adding PD-1 inhibitor to perioperative chemotherapy in LARC, and to validate post-radiotherapy β-HB elevation as a predictive biomarker for immunotherapy benefit.

Intestinal Low-Dose Radiotherapy Plus Immunochemotherapy for Conversion of Borderline Resectable/Unresectable Esophageal Squamous Cell Carcinoma

Esophageal cancer (EC) ranks among the leading malignant gastrointestinal tumors globally in terms of both incidence and mortality. Cases of EC in China account for over 50% of the global total, with squamous cell carcinoma being the primary pathological type. Locally advanced EC (LAEC), particularly cases where radical surgical resection is not feasible, exhibits high recurrence rates and low 5-year survival rates. However, studies have shown that patients with LAEC who undergo comprehensive treatment followed by surgery experience significantly prolonged survival and improved quality of life compared to those who do not receive surgical intervention. Current conversion treatment regimens under investigation include: chemotherapy alone, chemoradiotherapy, immunotherapy combined with chemotherapy, and immunotherapy combined with chemoradiotherapy-each of these approaches has distinct advantages and limitations. Immunochemotherapy has emerged as a current research focus: it not only demonstrates significantly superior efficacy compared to chemotherapy alone but also exhibits lower cumulative toxicity than radiotherapy-combined conversion regimens, resulting in a more favorable overall benefit-risk ratio. As such, it represents the most promising conversion treatment strategy. Retrospective and prospective clinical studies have shown that low-dose radiotherapy targeting the small intestine can enhance the anti-tumor response of immune checkpoint inhibitors (ICIs) in patients with advanced solid tumor, prolong their overall survival, and increase the incidence of the abscopal effect. Further mechanistic investigations have revealed that intestinal low-dose radiotherapy (ILDR) may augment the immune cancerous lethality by modulating the gut microbiota and their metabolic profiles. Based on the findings from these preliminary studies, the current research plans to conduct a prospective phase II single-arm clinical trial to investigate the efficacy and safety of ILDR combined with immunochemotherapy as conversion therapy in patients with borderline resectable or unresectable esophageal squamous cell carcinoma (BR/UR ESCC). This research plans to enroll at least 39 evaluable cases or a total of 39 cases in two seperated stages, focusing on patients with thoracic BR/UR ESCC. Patients will receive a single fraction of ILDR with a mean dose of 1 Gy, concurrently with 3 cycles of albumin-bound paclitaxel (260 mg/m² on day 1), cisplatin (75 mg/m² on day 1), and tislelizumab (200 mg on day 1). The efficacy and safety of the treatment will be evaluated throughout the study.

The Effect of the 4-7-8 Breathing Technique on Anxiety, Symptom Burden, and Sleep Quality During Chemotherapy

This study aims to determine the effects of the 4-7-8 breathing technique on anxiety, symptom severity, and sleep quality during treatment. A randomized controlled trial design was employed, involving 64 participants (intervention group: n=32; control group: n=32) undergoing their third treatment cycle. The intervention group received the 4-7-8 breathing technique twice daily for 21 days in addition to routine care, while the control group received routine care and standard supportive care. Data will be collected at pre-test and post-test stages using the Descriptive Information Form, the State-Trait Anxiety Inventory (STAI-State), the Edmonton Symptom Assessment System (ESAS), and the Pittsburgh Sleep Quality Index (PSQI). Data analysis will be performed using the SPSS 22.0 software.

ALND vs ART in Positive Sentinel Node After Neoadjuvant Therapy in Breast Cancer

In the case of primary surgery, in patients with sentinel node involvement, it has already been shown that omitting axillary lymph node dissection (ALND), often combining axillary radiotherapy (RT), does not worsen the prognosis and does significantly reduce the appearance of lymphedema. However, patients who have received neoadjuvant systemic treatment cannot benefit from this option, even though in the majority of those who have responded well to treatment, a residual disease in the armpit is low, but there are no studies yet published that supports the possibility of not performing lymphadenectomy. The primary endpoint is to evaluate wether axillary radiotherapy (ART) presents a lower risk of lymphedema with respect to lymphadenectomy (ALND) in patients with breast cancer who, after neoadjuvant systemic treatment (NST), present the sentinel node affected. Likewise, we will evaluate recurrences and overall survival in both groups. Finally, we will analyze the quality of life of these patients.

Effect of Gamified Sun Protection Education Provided to Chemotherapy Patients

Chemotherapy may cause photosensitivity and other skin reactions that can negatively affect patients' comfort, quality of life, and adherence to treatment. Appropriate sun protection behaviors are therefore important for patients receiving chemotherapy. This randomized controlled trial aims to evaluate the effect of gamified sun protection education on sun protection self-efficacy and sun protection behaviors in patients receiving chemotherapy. A total of 54 patients will be randomly assigned to two groups, with 27 participants in each group. Participants in the intervention group will receive gamified sun protection education, while participants in the control group will receive usual care. The educational intervention will be delivered over a two-week period. Sun protection self-efficacy and sun protection behaviors will be assessed at baseline and after completion of the two-week intervention.

Chemotherapy-Induced Hearing Loss and Health Inequality

This project aims to understand how platinum-based chemotherapy affects hearing function in cancer patients from different socioeconomic backgrounds in the North West of England. Platinum-based chemotherapy drugs, such as cisplatin, are ototoxic, meaning that they cause permanent damage to the hair cells of the ear, resulting in hearing loss. Patients from more deprived backgrounds face additional risk factors to their hearing health, including limited healthcare access, greater occupational noise exposure, and poorer overall health, making them more vulnerable to hearing loss. This is especially concerning as hearing loss can make communication more challenging, which creates a greater reliance on cognitive processes such as thinking and memory to navigate social interactions. This challenge is exacerbated when individuals experience cognitive dysfunction related to chemotherapy, commonly referred to as 'chemo brain'. Addressing these communication difficulties is crucial for promoting healthy ageing and maintaining social engagement. It is expected that cancer patients from the most deprived backgrounds would experience greater hearing loss following chemotherapy than those from less deprived backgrounds. As a secondary aim, this study will also investigate how hearing loss may affect cognitive function. Specifically, it will assess whether differences in speech-in-noise performance from pre- to post-treatment predict cognitive performance post-treatment, to understand if changes in hearing over time are associated with changes in cognition. The study will also explore how socioeconomic deprivation, cumulative chemotherapy dose, and treatment duration influence these relationships. By identifying disparities in hearing loss and possible associations with cognition, this research will help guide future hearing screening and intervention strategies for cancer patients.

Chemo Brain Prehab Project

Colorectal cancer is 37% higher in the North West than the national average and is treated by chemotherapy, including fluorouracil, capecitabine, and oxaliplatin. A side effect of these drugs is loss of memory, forgetfulness, and general brain fog, which can persist for months after the end of treatment. These symptoms are collectively known as 'chemo-brain'. An existing prehabilitation intervention that has been previously developed will be used, which increases fitness and reduces hospital length of stay in colorectal cancer surgery patients, to try to improve the symptoms of chemo-brain in those undergoing chemotherapy and improve quality of life.

Application of MRI Radiomics Features in Neoadjuvant Therapy of Head and Neck Squamous Cell Carcinoma

Head and neck squamous cell carcinoma is the sixth most common malignant tumor in the world. Neoadjuvant therapy, including neoadjuvant chemotherapy and immunotherapy, is recommended for patients with locally advanced head and neck cancer. The response to neoadjuvant therapy varies among the patients. It is reported that about 37% of the patients achieve pathological complete response after receiving neoadjuvant therapy, who would achieve a better prognosis compared with the patients with non-pathological complete response. It is significant to predict and assess response to neoadjuvant therapy for the patients with head and neck cancer accurately, which could assist in formulating individualized therapeutic regimens. MRI has good soft tissue resolution and is a common preoperative examination method. However, this method lacks the ability to accurately predict the probability of patients achieving pathological remission after neoadjuvant therapy. At present, it is a novel and effective method to construct a model to predict the efficacy of neoadjuvant therapy based on MRI image omics analysis, and certain achievements have been made in breast cancer and rectal cancer. In this study, multi-sequence MRI was combined with clinical risk factors to construct an imaging omics model to predict the probability of pathological complete remission of patients with head and neck squamous cell carcinoma after neoadjuvant therapy, and to accurately identify diagnostic imaging remission, so as to better assist clinical decision-making.

RegisterPROS - A Registry for Prostate Cancers

Prostate cancers are derived from epithelial cells in the prostate gland. Treatment options include surgery, medical (androgen signaling targeted and chemotherapy) and radiation therapy including radioligand therapy (RLT). Survival is linked to early and accurate diagnoses or to the effective detection of disease recurrence and/or treatment failure. One challenge is to develop accurate non-invasive tests that can detect prostate cancer disease activity. A second challenge is to evaluate the effectiveness of such biomarkers during the natural history of this disease (e.g., active surveillance). A third aim is to identify whether molecular markers can predict response to different therapies (either pre-treatment, or early on during the first few cycles of a therapy). RegisterPROS registry aims at collecting data and blood samples from patients being evaluated for PCa disease. Data will be entered prospectively and anonymized after informed consent. All physicians who treat PCas are invited to participate to the registry. Data will be evaluated within regular time frames, focusing on diagnostic accuracy for biomarkers in the different types of tumors, treatment modalities and patient outcomes (e.g. disease recurrence and survival), thereby contributing to an understanding of the role of biomarkers in tumor management.

Adjuvant Chemotherapy for High Malignant Prostate Cancer

This study aims to evaluate the efficacy of adjuvant docetaxel chemotherapy following radical radiotherapy in patients with localized high-grade prostate cancer. Eligible participants include those diagnosed with prostate cancer confirmed by biopsy or surgical pathology, with a Gleason score of 9-10 or containing a Gleason 5 component, and no evidence of distant metastasis. Patients will be divided into two groups: the standard treatment group receiving only radical treatment (radiotherapy or surgery), and the standard treatment plus chemotherapy group, receiving four to six cycles of docetaxel chemotherapy after standard treatment. The primary endpoint is Failure-Free Survival (FFS), with secondary endpoints including Biochemical Relapse-Free Survival (BRFS), Metastasis-Free Survival (MFS), Overall Survival (OS), and assessment of adverse events The study aims to better understand the impact of adjuvant chemotherapy on the prognosis of patients with high-risk prostate cancer and determine whether it improves survival outcomes.

Assessment of Adebelizumab Combined With Chemotherapy in Concurrent Radiotherapy Versus Sequential Radiotherapy as First-Line Treatment for Extensive-Stage Small Cell Lung Cancer

Immunotherapy combined with chemotherapy has emerged as the standard of care for patients with extensive-stage small cell lung cancer (ES-SCLC). The incorporation of thoracic radiotherapy can enhance treatment efficacy. Currently, the main types of research investigating immunotherapy combined with thoracic radiotherapy for untreated ES-SCLC are concurrent radiotherapy and sequential radiotherapy. The aim of this study is to evaluate the efficacy of adebelizumab in combination with chemotherapy, when administered concurrently with radiotherapy versus sequentially with radiotherapy, as a first-line treatment for ES-SCLC.

Aromatherapy Combined With Standard Antiemetic Therapy vs Standard Therapy Alone for Prevention of CINV in Breast Cancer Patients Receiving Highly Emetogenic Chemotherapy

This phase III, multicenter, randomized, open-label trial evaluates whether aromatherapy plus standard antiemetic therapy improves complete response (CR) of CINV compared with standard therapy alone in breast cancer patients receiving highly emetogenic chemotherapy (HEC). Despite guideline-recommended triple prophylaxis (5-HT3 antagonist, NK-1 antagonist, dexamethasone), 30-50% of patients still develop delayed CINV. Aromatherapy with lemon, lavender, and peppermint essential oils may provide additive benefit through olfactory-limbic and vagal pathways, but phase III evidence is lacking. 374 patients (aged 18-80) scheduled for at least two HEC cycles will be randomized 1:1, stratified by prior CINV. On chemo day, aromatherapy starts 30 min before and continues until 2 h after chemotherapy; on days 2-5, inhalation is at least 2 h daily.Primary endpoint: complete response (no vomiting, no rescue antiemetic) over 0-120 h. Key secondary endpoints: acute and delayed CR rates, complete/total control rates, time to treatment failure, quality of life (FLIE), anxiety, depression, sleep quality, and safety. Exploratory: plasma GDF15 dynamics and predictive value.

Gonadotropin-Releasing Hormone Agonists Benefit in Preserving the Ovarian Function in Premenopausal Breast Cancer Patients During Chemotherapy

The purpose of this study is to investigate the benefits of gonadotropin-releasing hormone agonist administration during chemotherapy on preserving ovarian function and Fertility in Premenopausal breast cancer patients, as assessed by anti-mullerian hormone levels, luteinizing hormone (LH), follicle-stimulating hormone (FSH), and estradiol (E2) levels.

Cognitive Impact Associated With Surgery For Gastric Or Esophageal Cancer

The primary objective of this observational study is to investigate the incidence of Post Operative Delirium (POD) after gastroesophageal cancer surgery. Secondary objectives are to investigate the relationship between POD, preoperative depression, frailty, quality of life, malnutrition and sarcopenia. Participants identified with POD will be asked (at the routine follow-up meeting after surgery) to participate in an qualitative interview, in order to understand the participant's experience of postoperative delirium. The main objective aims to answer: What is the incidence of POD after gastroesophageal cancer surgery.

The Effect of a Music-Assisted Mandala Intervention on Psychological Well-being and Quality of Life in Cancer Patients Undergoing Chemotherapy

Cancer is one of the most significant global health issues of our time. Chemotherapy, one of the methods used to treat cancer, not only treats the disease but also causes numerous physiological and psychological side effects that adversely affect quality of life. It has been reported that treatment adherence problems are more common in patients with a high symptom burden associated with these side effects. For this reason, it is crucial that patients have achieved psychological adaptation to their condition and treatment in order for the treatment to be effective, to ensure that toxicity is kept under control, and to ensure that the course of the disease progresses favourably. In cases of illness and failure to adhere to treatment, this can lead to unnecessary visits to the doctor, visits to A\&E, hospitalisation, and an increase in the use of healthcare services and associated costs; it may also result in the development of treatment resistance, an increased burden on patients and carers, disease progression, and even death. Various non-pharmacological approaches, such as exercise, expressing emotions and art therapy, can be used to ensure the patient's adherence to treatment. It has been reported that mandala practice, a form of art therapy, reduces anxiety, fatigue, insomnia and stress. In light of this information, the aim of this study is to assess the effect of mandala practice on psychological adjustment to the disease and treatment, and on quality of life, in cancer patients undergoing chemotherapy.

Targeted Induction Therapy for Stage III Unresectable EGFR Mutant Positive NSCLC

The subjects of this study are patients with unresectable stage III non-small cell lung cancer (NSCLC) who have EGFR mutations.

Iparomlimab and Tuvonralimab (QL1706) Plus Lenvatinib and Chemotherapy for Extrapulmonary Neuroendocrine Carcinoma

The aim of this prospective, randomized, controlled clinical trial is to evaluate the efficacy and safety of iparomlimab and tuvonralimab injection (QL1706) plus lenvatinib and etoposide-based platinum chemotherapy, consisting of etoposide plus cisplatin or carboplatin, compared with etoposide-based platinum chemotherapy alone as first-line treatment for patients with extrapulmonary neuroendocrine carcinoma. Potential predictive biomarkers will also be explored through analyses of tumor tissue, peripheral blood, and relevant clinical and pathological data.

The Effect of a Virtual Reality-Based Mindfulness Intervention on Anxiety, Comfort, Sleep, and Fatigue in Breast Cancer Patients Undergoing Chemotherapy

Breast cancer is a public health issue with a high incidence among women worldwide, and its prevalence continues to increase each year. A breast cancer diagnosis brings significant physical, emotional, social, economic, and occupational changes. Chemotherapy, one of the most commonly used treatment modalities in cancer therapy, causes various physical and emotional symptoms while treating the disease. However, it is well known that these symptoms induced by chemotherapy can be prevented or alleviated through effective treatment and nursing interventions. Recently, virtual reality (VR) and mindfulness-based interventions have been reported as effective tools and methods for managing the physical and psychological symptoms experienced by cancer patients. The present study aims to evaluate the effect of a VR-integrated mindfulness-based intervention on anxiety, comfort, sleep, and fatigue levels among women newly diagnosed with breast cancer, both before and during chemotherapy treatment. The study is designed as a randomized controlled trial (RCT). The study population will consist of individuals diagnosed with breast cancer at the Oncology Outpatient Clinic of Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital between May 2025 and December 2026. The study sample will include female breast cancer patients who are scheduled to receive adjuvant chemotherapy, meet the inclusion criteria, and volunteer to participate in the study. According to the power analysis (with a 30% additional error margin), a total of 50 participants will be included - 25 in the intervention group and 25 in the control group. The data will be collected using the following instruments: Patient Information Form, Beck Depression Inventory, Cancer Fatigue Scale, General Comfort Questionnaire-Short Form, State Anxiety Inventory, Jenkins Sleep Scale, and the Mindfulness-Based Self-Efficacy Scale. It is expected that, as a result of this study, compared to the control group, participants in the intervention group who receive the VR-Mindfulness intervention during breast cancer treatment will demonstrate reduced levels of fatigue and anxiety and improved comfort and sleep quality.