Phase II Study of Pre-Surgery Chemotherapy and Tislelizumab Treatment for Locally Advanced Rectal Cancer

What this Trial Is About

Researchers are evaluating the safety and early effectiveness of combining chemotherapy with the PD-1 inhibitor Tislelizumab for patients with locally advanced rectal cancer. This phase II, single-center study focuses on patients diagnosed with stage T3 or T4 rectal adenocarcinoma without distant metastases. The trial is designed to assess clinical and pathological complete responses after treatment and surgery. Participants will receive three cycles of a combination chemotherapy regimen CAPOX Oxaliplatin and Capecitabine along with Tislelizumab over nine weeks prior to surgery. After treatment, there will be a two-week rest before surgery, followed by decisions on additional therapy based on postoperative pathology. Treatment may continue unless disease progresses, intolerable side effects occur, or consent is withdrawn. Safety follow-ups occur approximately 30 and 90 days after treatment, and survival follow-up continues every three months for three years. During the study, participants will undergo laboratory tests and medical evaluations at specified times. The key outcomes include measuring clinical complete response at eight weeks after chemotherapy and pathological complete response after surgery. Participants are expected to spend about four to six hours during pre-study, study, and end-of-study visits. Long-term follow-up every three months will monitor survival and overall health status for up to 36 months from enrollment.

Neoadjuvant Chemotherapy and PD-1 Inhibitor for Locally Advanced Rectal Cancer（CONTROL-01）