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NOT YET RECRUITING
NCT07879586
PHASE2/PHASE3

Neoadjuvant Chemoradiotherapy Plus PD-1 Blockade ± CTLA-4 Blockade for High-Risk Locally Advanced Rectal Cancer (pMMR/MSS): A National Multicenter, Prospective, Randomized Controlled Trial

Sponsor: Yao Hongwei

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to learn whether adding ipilimumab N01 to standard pre-surgery treatment with radiation, chemotherapy, and sintilimab can improve outcomes for people with high-risk, locally advanced rectal cancer whose tumors are mismatch repair-proficient and microsatellite stable (pMMR/MSS). The study will also evaluate the safety of these treatments and whether some participants may be able to avoid major rectal surgery after a strong response.

Official title: Neoadjuvant Therapy Combined With Dual Immunotherapy for Rectal Cancer: A Clinical Study

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2026-10-01

Completion Date

2032-10-01

Last Updated

2026-10-19

Healthy Volunteers

No

Interventions

DRUG

Ipilimumab & Sintilimab

In Experimental group,subjects will receive long-course neoadjuvant radiotherapy, followed by chemotherapy combined with immunotherapy: Ipilimumab \& Sintilimab.

DRUG

Sintilimab

In Control group,subjects will receive long-course neoadjuvant radiotherapy, followed by chemotherapy combined with immunotherapy: Sintilimab.