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)

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Sir Run Run Shaw Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• dMMR/MSI-H-type Rectal Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Ipalolimab and Tovorilimab	1.Active Ingredients: Ipalolimab and Tovorilimab (a dual-functional combination antibody consisting of Ipalolimab, a recombinant humanized monoclonal antibody targeting programmed death receptor-1 \[PD-1\], and Tovorilimab, a recombinant humanized monoclonal antibody targeting cytotoxic T-lymphocyte-associated protein-4 \[CTLA-4\]). 2.Specification: 50 mg (2 mL) per vial. 3.Dosage and Administration: Administer via intravenous infusion at a recommended dose of 5 mg/kg every 3 weeks.

Timeline

• Start date: 2025-08-20
• Primary completion: 2027-08-30
• Completion: 2030-08-30
• First posted: 2025-09-08
• Last updated: 2025-12-02

Locations

1 site across 1 country: China