Actively Recruiting

Phase 3
Age: 18Years - 75Years
All Genders
NCT05797077

Postoperation Maintenance Therapy for Resectable Liver Metastases of Colorectal Cancer Guided by ctDNA

Led by Sixth Affiliated Hospital, Sun Yat-sen University · Updated on 2023-04-04

346

Participants Needed

1

Research Sites

417 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The goal of this clinical trial is to compare in resectable liver metastases colorectal cancer patients.The main question it aims to answer is to investigate whether the progression-free survival (PFS) of resectable colorectal liver metastasis (CRLM) patients with positive ctDNA after surgery is superior with the combination of adjuvant chemotherapy and maintenance therapy compared to adjuvant chemotherapy alone.

CONDITIONS

Official Title

Postoperation Maintenance Therapy for Resectable Liver Metastases of Colorectal Cancer Guided by ctDNA

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Both males and females, aged 18-75 years
  • Patients with liver metastatic colorectal cancer who have undergone R0 resection based on MDT evaluation, including those treated with ablation achieving similar R0 effect
  • Postoperative ctDNA-positive patients
  • ASA grade less than IV and/or ECOG performance status score 2 or less
  • Participants must understand the study and voluntarily sign informed consent
Not Eligible

You will not qualify if you...

  • Patients with distant metastases to other sites such as pelvis, ovaries, or peritoneum
  • History of other malignant tumors
  • Severe liver, kidney, cardiorespiratory, or coagulation dysfunction or other diseases that prevent chemotherapy tolerance
  • Allergy to any study components
  • Prior investigational drug treatment for tumors
  • Severe uncontrolled infections or other severe uncontrolled diseases
  • Factors affecting study results or leading to early termination like alcoholism, drug abuse, serious diseases, or severe lab abnormalities
  • History of severe mental illness
  • Pregnant or lactating women
  • Other clinical or laboratory conditions deemed unsuitable by researchers

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

The Sixth Affiliate Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, China

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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