drugset / Trial / NCT06364384

Radical Concurrent Chemoradiotherapy With DDP/5-FU and PD-1 Antibody for Non-metastatic Rectal Squamous Cell Carcinoma

NCT06364384

Phase 2 Recruiting 20 enrolled Sixth Affiliated Hospital, Sun Yat-sen University
NaSingle-groupOpen-labelTreatment

Summary

The goal of this clinical trial is to learn if PD-1 monoclonal antibody combined with radical chemoradiotherapy works to treat rectal squamous cell carcinoma (rSCC). lt will also learn about the safety of the regime. The main questions it aims to answer are: Does PD-1 monoclonal antibody combined with radical chemoradiotherapy improve survival prognosis? What is the complete response rate (CCR) of the regime? Researchers will compare PD-1 monoclonal antibody combined with radical chemoradiotherapy to previous study to see if this regime works to treat rSCCs. Participants will receive chemotherapy with DDP and 5-FU, immunotherapy with PD-1 monoclonal antibody and radiotherapy with a total dose of 50-54GY.

Timeline

Start
2024-04-12
Primary completion
2026-09-08
Completion
2029-06-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Sintlimab Monoclonal antibody 200 mg Intravenous
Background DDP Unknown 75 mg/m2 Intravenous
Background fluorouracil Small molecule 1000 mg/m2 Intravenous