drugset / Trial / NCT06647680

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

NCT06647680 ↗

Phase 2 Recruiting 35 enrolled The Affiliated Hospital of Qingdao University
NaSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2025-06-01
Primary completion
2026-12-01
Completion
2027-12-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Capecitabine Small molecule — —
Subject Oxaliplatin Small molecule — —
Subject Tislelizumab Monoclonal antibody — —

Indications