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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

NCT06936488 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2025-04-20

No results posted yet for this study

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

DRUG

Ivonescimab,TAS-102

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

Sponsors & Collaborators

  • Huai'an First People's Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-01
Primary Completion
2026-10-31
Completion
2026-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06936488 on ClinicalTrials.gov