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

Sponsor
Huai'an First People's Hospital
Study ID
NCT06936488
Status
Enrolling By Invitation

Conditions

  • MSS/pMMR Type Metastatic Colorectal Adenocarcinoma Patients

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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)

Key Dates

Start date
Mar 1, 2025
Status verified
Dec 2024
Primary completion
Oct 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
35 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Ivonescimab

Primary Outcome Measure

PFS rate at 18 weeks [ Time Frame: At the end of Cycle 6 (each cycle is 28 days) ]