Study of PD-1 Inhibitor Tislelizumab With Advanced Radiotherapy and Chemotherapy for Locally Advanced Rectal Cancer

What this Trial Is About

Researchers are evaluating the safety and effectiveness of combining tislelizumab, a PD-1 inhibitor, with simultaneous integrated boost intensity-modulated radiotherapy SIB-IMRT for treating locally advanced rectal cancer. This randomized controlled trial includes patients with stage T3-4 rectal cancer or positive regional lymph nodes without distant metastases, aiming to explore a new adjuvant chemotherapy model using PD-1 inhibitors alongside radiotherapy. Participants are randomly assigned to two groups. The experimental group receives concurrent SIB-IMRT radiotherapy with capecitabine chemotherapy, completes 2 to 4 cycles of XELOX chemotherapy, and receives intravenous tislelizumab every 21 days for at least 4 cycles. The control group receives standard intensity-modulated radiotherapy IMRT without tislelizumab, combined with the same chemotherapy regimens. During the study, tumor size is assessed by MRI or CT imaging, and side effects are carefully recorded. The main outcome measured is the complete response rate between 12 and 18 weeks after treatment. Secondary outcomes include monitoring side effects over 6 months and 3 years, as well as overall survival and disease-free survival over 3 years. Participation includes regular treatment cycles and follow-up evaluations to assess both safety and effectiveness up to three years after treatment begins.

Neoadjuvant Chemotherapy With PD-1 Inhibitors Combined With SIB-IMRT in the Treatment of Locally Advanced Rectal Cancer