NCT06936488

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

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: Huai'an First People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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)

Conditions

• MSS/pMMR Type Metastatic Colorectal Adenocarcinoma Patients

Interventions

Type	Name	Description
DRUG	Ivonescimab,TAS-102	Ivonescimab,20mg/kg,i.v.,D1,Q3w TAS-102,35mg/m2,bid,D1-5,Q2W

Timeline

• Start date: 2025-03-01
• Primary completion: 2026-10-31
• Completion: 2026-12-31
• First posted: 2025-04-20
• Last updated: 2025-04-20

Locations

1 site across 1 country: China