Study Comparing Chemoradiotherapy With and Without Tislelizumab for Treating Locally Advanced Rectal Cancer

What this Trial Is About

Researchers are studying neoadjuvant chemoradiotherapy combined with the drug tislelizumab compared to chemoradiotherapy alone for patients with locally advanced rectal cancer. The trial aims to evaluate how effective and safe this combined treatment is, as well as its impact on rectal or anal retention and quality of life. This study includes phase II and phase III parts and is sponsored by Beijing Friendship Hospital. Participants in the experimental group will receive a long course of chemoradiotherapy over five weeks with capecitabine and radiation. They will also receive tislelizumab intravenously on the first day of weeks 2, 5, and 8 after starting radiotherapy. Following this, two 14-day cycles of the CAPOX chemotherapy regimen will be given. The control group will receive the same chemoradiotherapy and CAPOX treatment but without tislelizumab. After treatment, patients will have examinations including colonoscopy and MRI to guide further care. During the study, participants will undergo assessments such as colonoscopy and MRI about 8 to 10 weeks after radiation therapy. Researchers will monitor outcomes like complete response within 10 days after surgery or clinical complete response 13 weeks after starting radiotherapy. Safety will be evaluated by tracking adverse events during treatment and immune-related side effects after tislelizumab. The total duration depends on surgery timing and follow-up. The study uses a randomized design and single masking to compare treatments.

A Series of Neoadjuvant Chemoradiotherapy Combined With Immunotherapy for Locally Advanced Rectal Cancer