Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
All Genders
NCT06980532

Glumetinib Combined With Fruquintinib in the Treatment of MET Amplification or Protein Overexpression in Third-Line Unresectable Metastatic Colorectal Cancer

Led by Liu Huang · Updated on 2025-05-20

42

Participants Needed

1

Research Sites

192 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Glumetinib combined withFruquintinib in the treatment of MET amplification or protein overexpression in third-line unresectable metastatic colorectal cancer: evaluation of efficacy and safety

CONDITIONS

Official Title

Glumetinib Combined With Fruquintinib in the Treatment of MET Amplification or Protein Overexpression in Third-Line Unresectable Metastatic Colorectal Cancer

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients 18 years or older
  • Patients who fully understand the study and voluntarily sign informed consent
  • Patients with unresectable metastatic colorectal cancer confirmed microsatellite stable
  • Patients with MET amplification or protein overexpression confirmed by specific tests
  • Patients whose disease has progressed after two prior standard anti-tumor treatments
  • Patients with at least one measurable tumor lesion according to RECIST1.1 criteria
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
  • Expected survival time of 3 months or more
  • Adequate blood counts: ANC ≥1.5 x 10^9/L, platelets ≥75 x 10^9/L, hemoglobin ≥80 g/L, WBC ≥3.0 x 10^9/L
  • Adequate liver and kidney function within specified limits
  • Coagulation tests (APTT, INR, PT) less than or equal to 1.5 times normal upper limit
  • Women of childbearing age must have a negative pregnancy test within 7 days before enrollment and agree to contraception during and 6 months after treatment
  • Male participants must agree to use contraception during and 6 months after the study
Not Eligible

You will not qualify if you...

  • Previous treatment with MET inhibitors
  • Patients with metastatic colorectal cancer that is MSI-H or dMMR
  • Patients with BRAF gene mutation who have not received BRAF or MEK inhibitors
  • Patients with severe active bleeding, active peptic ulcers, unhealed gastrointestinal perforations, or fistulas
  • Known hypersensitivity to study drugs or their components
  • Severe uncontrolled infections or other serious uncontrolled diseases including moderate or severe kidney injury
  • Active hepatitis B or C infection with viral loads above specified levels
  • Human immunodeficiency virus (HIV) infection
  • Current or past other malignant tumors except certain controlled cancers
  • Pregnant or breastfeeding women or those unwilling to use contraception
  • Patients with other malignant tumors requiring treatment
  • Any condition that the investigator judges makes the patient unsuitable for the study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Huazhong University of Science and Technology

Wuhan, Hubei, China, 430000

Actively Recruiting

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Research Team

X

Xianglin Yuan, PhD,MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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