Node-Sparing Short-Course Radiotherapy Combined with Chemotherapy, Bevacizumab, and PD-1 Inhibitor Versus Chemotherapy and Bevacizumab Alone for Metastatic pMMRMSS Colorectal Cancer A Randomized Phase IIIII Study

What this Trial Is About

Researchers are studying metastatic colorectal cancer, specifically patients with proficient mismatch repair pMMR and microsatellite stable MSS tumors, who currently have limited treatment options. This phase IIIII trial aims to evaluate if adding node-sparing modified short-course radiotherapy to chemotherapy, bevacizumab, and PD-1 inhibitor therapy can improve the objective response rate and progression-free survival compared to chemotherapy plus bevacizumab alone. The study also focuses on treatment tolerance and overall prognosis in these patients. Participants are assigned randomly to one of two groups. The experimental group receives node-sparing modified short-course radiotherapy followed by eight cycles of FOLFOX chemotherapy combined with bevacizumab and a PD-1 inhibitor, then maintenance therapy with bevacizumab, PD-1 inhibitor, and 5-fluorouracil every two weeks. The comparison group receives eight cycles of FOLFOX chemotherapy with bevacizumab, followed by maintenance with bevacizumab and 5-fluorouracil every two weeks. The study treatments are administered as first-line therapy. During the study, participants will have measurable lesions assessed over up to 36 months to determine objective response rate and progression-free survival. Researchers will also monitor duration of response, disease control rate, overall survival, treatment-related adverse effects, and time to response. Participants provide tumor tissue and blood samples for research, and their health status, organ function, and tumor responses will be regularly evaluated throughout the trial. The total study participation may last several years, with ongoing safety monitoring.

Node-Sparing Short-Course Radiotherapy Plus Chemotherapy, Bevacizumab and PD-1 Inhibitor in Metastatic pMMR/MSS Colorectal Cancer (MODIFI-CRC)