Clinical Research Directory

Ivarmacitinib Combined With Camrelizumab and Fruquintinib for Patients With Metastatic Colorectal Cancer After Failure of Second-line or Later Treatment

For patients with metastatic colorectal cancer (mCRC) who have failed two or more lines of standard therapy, treatment options are extremely limited, and the prognosis remains poor, with objective response rates (ORRs) generally below 5%. This is particularly challenging for patients with microsatellite-stable (MSS)/proficient mismatch repair (pMMR) tumors, who constitute the vast majority of patients with mCRC. The immunologically "cold" tumor microenvironment (TME) in these patients contributes to widespread primary resistance to PD-1 inhibitor monotherapy. A key mechanism underlying this resistance is the sustained activation of JAK/STAT signaling, which promotes immunosuppression mediated by myeloid-derived suppressor cells (MDSCs) and other immunosuppressive components, thereby limiting T-cell activity and the efficacy of strategies that solely reinvigorate T cells. To address this challenge, the investigators propose an innovative combination strategy aimed at remodeling the TME and alleviating immunosuppression. The investigators hypothesize that ivarmacitinib, a highly selective JAK1 inhibitor, may attenuate the immunosuppressive TME through modulation of JAK/STAT signaling, potentially converting "cold" tumors into "hot" tumors and enhancing the antitumor activity of camrelizumab, a PD-1 inhibitor, in combination with fruquintinib, a tyrosine kinase inhibitor (TKI). Accordingly, a single-arm, single-center, exploratory phase II clinical study was designed to enroll 33 patients with mCRC who have failed multiple lines of prior therapy. The study aims to evaluate the ORR, survival outcomes, and safety of this combination regimen. The findings are expected to provide preliminary evidence for a potential new therapeutic approach for this heavily pretreated patient population and establish a foundation for subsequent larger confirmatory studies.

Evaluation of the Safety and Efficacy of Treatment w/High Dose Melphalan Given Directly Into the Liver Followed by Treatment w/Approved Cancer Treatment or Approved Cancer Treatment Alone in Patients w/ Metastatic Colorectal Cancer w/Liver Dominant Disease

The goal of this clinical trial is to learn if using a liver-directed therapy with high dose chemotherapy followed by approved cancer treatment to treat patients with colorectal cancer that has spread to the liver is safe and tolerable. The clinical trial will also learn if the liver-directed therapy with high dose chemotherapy works on the disease in the liver. Investigators will compare the use of the liver-directed therapy with high dose chemotherapy followed by approved cancer treatment or approved cancer treatment alone. Participants will: * Undergo up to two liver-directed therapy with high dose chemotherapy procedures followed by approved cancer treatment or take approved cancer treatment alone * Visit clinic at least every two weeks for checkups and tests * Complete scans approximately every two months

Nimotuzumab Combined With Trifluridine/Tipiracil in the Treatment of Refractory Metastatic Colorectal Cancer

This is a randomized, double-blind, placebo-controlled, multicenter study. The main purpose of the study is to evaluate the clinical efficacy and safety of nimotuzumab combined with trifluridine/tipiracil in third-line and beyond for the treatment of metastatic colorectal cancer (mCRC). This study planned to be divided into two parts: Part A and Part B. Part A (safety run-in) with a 3 + 3 study design, which primary endpoint is safety; Part B (main study) with a prospective, randomized, double-blind, placebo-controlled design, which primary endpoint is overall survival (OS).

A Phase Ib/III Study of Suvemcitug Plus FTD/TPI in Participants With Refractory Metastatic Colorectal Cancer

The primary goal of Phase Ib Study is to evaluate the safety of Suvemcitug in combination with trifluridine/tipiracil tablets in colorectal cancer participants. The primary goal of Phase III Study is to evaluate the efficacy of Suvemcitug in combination with trifluridine/tipiracil tablets in colorectal cancer participants. Researchers will compare Suvemcitug + trifluridine/tipiracil tablets with placebo (a look-alike substance that contains no drug)+ trifluridine/tipiracil tablets to see if Suvemcitug + trifluridine/tipiracil tablets works better in treating refractory metastatic colorectal cancer.

Trifluridine/Tipiracil Plus Fruquintinib vs. Trifluridine/Tipiracil Plus Bevacizumab in Refractory Metastatic Colorectal Cancer: A Randomized, Controlled, Open-Label, Non-Inferiority Trial

This study is an investigator-initiated, prospective, multicenter, randomized, controlled, open-label, non-inferiority trial designed to evaluate the efficacy and safety of trifluridine/tipiracil plus fruquintinib versus trifluridine/tipiracil plus bevacizumab in the treatment of refractory metastatic colorectal cancer.

Vorbipiprant (CR6086) / Balstilimab (AGEN2034) Combination in Stage IV Refractory pMMR - MSS CRC, and Other Metastatic GI Cancers

This Phase Ib/IIa study comprises a Main Study and a Study Extension. The Main Study has been designed according to a 3+3 Dose Escalation/dose Expansion design in refractory pMMR-MSS mCRC patients. The fixed-dose Expansion phase will be conducted at the recommended dose for expansion (RDE), with the purpose of generating additional and more robust safety and efficacy data. 27 patients are predicted in the Dose Escalation phase and 52 in the Expansion phase, respectively. The Study Extension explores in other metastatic GI cancers the Vorbipiprant (CR6086) RDE obtained in the Main Study. 27 patients are predicted. No control arm was included, as the target patient population of this study consists of patients in whom the overall survival is less than 6 months and treatment options are very limited and often poorly tolerated, making unlikely that the study results can be significantly biased.

Amplitude Modulated Radiofrequency Electromagnetic Field Treatment Combined With TAS-102 (Lonsurf) and Bevacizumab in Refractory Metastatic Colorectal Cancer

Combined chemotherapy and radiofrequency electromagnetic field treatment for patients with liver dominant refractory metastatic colorectal cancer