Clinical Trial

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)

Study acronym: Neo-IT
Active, Not Recruiting Phase 2
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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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-08-29.
Trial Details
NCT Number NCT07160647
Lead Sponsor Sir Run Run Shaw Hospital
Conditions dMMR/MSI-H-type Rectal Adenocarcinoma
Enrollment 29 participants
Start Date 2025-08-20
Primary Completion 2027-08-30 (estimated)
Study Completion 2030-08-30 (estimated)
Updated on ClinicalTrials.gov 2025-12-02