drugset / Trial / NCT07160647

The Efficacy and Safety of Neoadjuvant Therapy With Iparomlimab and Tuvonralimab in Locally Advanced MSI-H/dMMR Colorectal Cancer: An Prospective, Single-Arm Study (Neo-IT)

NCT07160647 ↗

Phase 2 Active not recruiting 29 enrolled Sir Run Run Shaw Hospital
NaSingle-groupOpen-labelTreatment

Summary

Immunotherapy may bring revolutionary changes to the preoperative neoadjuvant treatment mode for dMMR/MSI-H locally advanced rectal cancer. According to the existing theory, the use of Iparomlimab and Tuvonralimab may be the best solution. In this study, the investigators will perform single-cell sequencing of participants tissue samples, fully explore the multi-dimensional omics information of tumors and microenvironments, explore the characteristics of the treatment benefit population, and try to construct an efficacy prediction model to screen the treatment benefit population early and implement precise treatment.

Timeline

Start
2025-08-20
Primary completion
2027-08-30
Completion
2030-08-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Ipalolimab Monoclonal antibody — Intravenous
Subject Tovorilimab Monoclonal antibody — Intravenous

Indications