Phase II Study of Short-Term Radiotherapy Combined With Iparomlimab and Tuvonralimab QL1706, Regorafenib, and CAPOX as Pre-Surgery Treatment for Locally Advanced Rectal Cancer

What this Trial Is About

Researchers are evaluating a new combination of treatments for adults with locally advanced rectal cancer that is proficient in mismatch repairmicrosatellite stable pMMRMSS. This Phase II, multicenter, randomized trial compares the effects of short-term radiotherapy combined with a bispecific antibody Iparomlimab and Tuvonralimab, also called QL1706, regorafenib, and CAPOX chemotherapy given before surgery. The study also aims to explore how various biomarkers in blood, urine, feces, and tumor tissue relate to treatment effectiveness. Participants are randomly assigned to one of two groups. Group A receives two cycles of QL1706, regorafenib, and CAPOX as induction therapy, followed by short-course radiotherapy, then four additional cycles of the same drugs. Group B starts with short-course radiotherapy and then receives six cycles of QL1706, regorafenib, and CAPOX as consolidation therapy. The radiotherapy is delivered as 25 Gy total over five sessions. After completing their assigned neoadjuvant therapies, patients are evaluated for response and then undergo surgery or watchful waiting based on results. During the study, participants will be monitored through clinical evaluations, imaging, and biomarker sample collection from blood, urine, stool, and tumor tissue. Researchers will assess outcomes such as complete response, tumor shrinkage, surgical success, and organ preservation over time. Safety and side effects will be tracked up to 30 days after treatment ends. Follow-up will continue to evaluate event-free and overall survival up to several years after therapy. Patient compliance and sample contributions are also part of the study requirements.

Radiotherapy Plus Iparomlimab and Tuvonralimab (QL1706), Regorafenib, and CAPOX as Neoadjuvant Therapy for pMMR/MSS LARC.