drugset / Trial / NCT07113275

A Clinical Trial Comparing Long-Course Versus Short-Course Radiotherapy Followed by Immunotherapy Combined With Total Neoadjuvant Therapy (TNT) to Long-Course Radiotherapy Followed by TNT in Locally Advanced Rectal Cancer

NCT07113275

Phase 3 Recruiting 444 enrolled Tao Zhang
RandomizedParallel-groupSingle-blindTreatment

Summary

This study is a national multicenter, prospective randomized, placebo- controlled Phase III clinical trial designed to investigate the potential therapeutic benefit of immunotherapy combined with total neoadjuvant therapy (TNT) and to compare the efficacy of different radiotherapy modalities followed by immunotherapy.

Timeline

Start
2026-05-15
Primary completion
2028-01-01
Completion
2028-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Serplulimab Monoclonal antibody 300 mg Intravenous
Background Capecitabine Small molecule 1000 mg/m2 Oral
Background Oxaliplatin Small molecule 130 mg/m2 Intravenous

Indications