Phase II Randomized Trial of Neoadjuvant Chemoradiation with Tislelizumab for Mid-Low Locally Advanced Rectal Cancer

What this Trial Is About

Researchers are evaluating the effectiveness and safety of adding Tislelizumab, a PD-1 inhibitor, to long-course chemoradiation treatment before surgery for patients with mid-low locally advanced rectal cancer. This phase II, multi-center, open-label, randomized trial compares two experimental groups receiving chemoradiation combined with Tislelizumab at different timings and a control group receiving chemoradiation alone. The study focuses on patients aged 18 to 75 years with stage IIIII rectal adenocarcinoma without metastasis, aiming to improve treatment outcomes such as complete tumor response and survival rates. Participants will be randomly assigned to one of three groups Experiment Arm 1 receives chemoradiation plus concurrent Tislelizumab starting on Day 8 of radiation Experiment Arm 2 receives chemoradiation plus sequential Tislelizumab starting two weeks after radiation completion Control Arm receives chemoradiation only. All groups undergo total mesorectal excision TME surgery after 6 to 12 weeks post-radiation. Tislelizumab is administered at 200 mg per dose, three times at three-week intervals for the experimental arms. During the study, participants will undergo various assessments including tumor response evaluation within 10 days after surgery, adverse event monitoring, and follow-up for disease-free and overall survival up to five years post-operation. Researchers will also assess sphincter preservation rates, surgical complications, immune-related side effects, and quality of life scores throughout the study period. Data will be analyzed to compare outcomes between groups and determine the potential benefits and risks of adding Tislelizumab to standard chemoradiation.

Neoadjuvant Long-course Chemoradiation Plus PD-1 Blockade for Mid-low Locally Advanced Rectal Cancer