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

To evaluate the safety and preliminary efficacy of preoperative chemotherapy and PD-1 inhibitor Tislelizumab for Rectal Cancer patients.Go through laboratory and medical tests to verify eligibility to enter the study, receive the experimental combination of drugs CAPOX (Oxaliplatin and Capecitabine) for 3 cycles prior to surgery and undergo laboratory tests and study procedures on specified days during the study period, complete end of study evaluations and tests, and participate in post-study follow up every three months for three years.

NCT Number	NCT06647680
Lead Sponsor	The Affiliated Hospital of Qingdao University
Conditions	Rectal Cancer Patients
Enrollment	35 participants
Start Date	2025-06-01
Primary Completion	2026-12-01 (estimated)
Study Completion	2027-12-01 (estimated)
Updated on ClinicalTrials.gov	2026-03-06