drugset
drugset / Trial / NCT07127497

Clinical Study on the Safety and Relationship of Sintilimab Combined With Chemotherapy in Neoadjuvant Treatment of Locally Advanced Rectal Adenocarcinoma

NCT07127497 ↗

Phase 2 Active not recruiting 50 enrolled The First Affiliated Hospital of Anhui Medical University
NaSingle-groupOpen-labelTreatment

Summary

This study is designed as a single-center, phase II exploratory clinical trial to evaluate the pathological response rate and safety of sintilimab (PD-1 inhibitor) combined with XELOX regimen (oxaliplatin + capecitabine) for neoadjuvant treatment of LARC. The study focuses on the pMMR/MSS patient population and attempts to provide a new treatment option for patients who cannot tolerate radiotherapy or need to preserve organ function.

Timeline

Start
2022-06-01
Primary completion
2026-10-01
Completion
2028-10-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Sintilimab Monoclonal antibody 3 mg/kg Intravenous
Subject Sintilimab Monoclonal antibody 200 mg Intravenous
Background Capecitabine Small molecule 1000 mg/m2 Oral
Background Oxaliplatin Small molecule 130 mg/m2 Intravenous

Indications

rectum adenocarcinoma