Clinical Trial

A Prospective, Single Arm, Open Label, Phase II Clinical Study on the Efficacy and Safety of Ivonescimab (AK112) Combined With TAS-102 in the Treatment of Refractory MSS/pMMR Advanced Colorectal Cancer

Enrolling by Invitation
View on ClinicalTrials.gov →
Summary
A Prospective, Single Arm, Open Label, Phase II Clinical Study on the Efficacy and Safety of Ivonescimab (AK112) Combined With TAS-102 in the Treatment of Refractory MSS/pMMR Advanced Colorectal Cancer Main purpose: Evaluate the efficacy and safety of the combination therapy of Ivonescimab (AK112) and TAS-102 in the treatment of refractory MSS/pMMR advanced colorectal cancer Exploratory purpose: Evaluation of the relationship between immune markers, patient efficacy, and prognosis in the treatment of refractory MSS/pMMR advanced colorectal cancer with the combination of Ivonescimab (AK112) and TAS-102 Study endpoint Primary endpoint: Researchers evaluated the PFS rate at 18 weeks based on RECIST v1.1. Secondary endpoint: ORR, DCR, PFS, and OS evaluated based on RECIST v1.1. The incidence and severity of adverse events (AEs)
Trial Details
NCT Number NCT06936488
Lead Sponsor Huai'an First People's Hospital
Conditions MSS/pMMR Type Metastatic Colorectal Adenocarcinoma Patients
Enrollment 35 participants
Start Date 2025-03-01
Primary Completion 2026-10-31 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-04-20