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Recruiting NCT05797077

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

Phase III Interventional Colorectal Cancer Liver Metastases Circulating Tumor Cell Cancer, Therapy-Related

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Colorectal resection surgery., FOLFOX chemotherapy regimen, Capecitabine.
Who it may be relevant to
Registry conditions: Colorectal Cancer, Liver Metastases, Circulating Tumor Cell, Cancer, Therapy-Related. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Postoperation Maintenance Therapy for Resectable Liver Metastases of Colorectal Cancer Guided by ctDNA: a Multicenter, Randomized, Controlled, Phase III Clinical Trial.

Overview

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.

Interventions

  • Procedure Colorectal resection surgery.
    Colorectal cancer radical resection combined with liver metastasis resection or ablation.
  • Drug FOLFOX chemotherapy regimen
    Chemotherapy regimens recommended include oxaliplatin-based CapeOx or FOLFOX regimens, or single-agent 5-FU/LV, capecitabine, or combination with targeted therapy.
  • Drug Capecitabine
    Maintenance therapy is recommended to be continued with low-toxicity drugs such as 5-FU/LV or capecitabine, and may be combined with targeted therapy. Treatment should be discontinued once ctDNA testing is negative.

Primary outcome measures

  • 3-years Progression Free Survival [Time frame: 3 years after operation.]
  • 5-years Progression Free Survival [Time frame: 5 years after operation.]
Secondary outcome measures (3)
  • 3-years overall survival [Time frame: 3 years after operation.]
  • 5-years overall survival [Time frame: 5 years after operation.]
  • Complication [Time frame: 5 years.]

Eligibility criteria

Inclusion criteria

  • Both males and females, aged 18-75 years;
  • Patients with liver metastatic colorectal cancer who have undergone R0 resection based on MDT evaluation (including patients whose metastases have been treated with ablation achieving similar R0 resection effect);
  • Postoperative ctDNA-positive patients;
  • ASA grade < IV and/or ECOG performance status score ≤ 2;
  • Participants must have a full understanding of the study and voluntarily sign an informed consent form.

Exclusion criteria

  • Patients with distant metastases to other sites, including the pelvis, ovaries, peritoneum, etc.
  • Patients with a history of other malignant tumors.
  • Patients with severe liver or kidney dysfunction, cardiorespiratory dysfunction, coagulation dysfunction, or underlying diseases that cannot tolerate chemotherapy.
  • Patients who are allergic to any component of the study.
  • Patients who have received other tumor-related investigational drug treatments.
  • Patients with severe uncontrolled recurrent infections or other severe uncontrolled accompanying diseases.
  • Patients with other factors that may affect the study results or lead to early termination of the study, such as alcoholism, drug abuse, other serious diseases requiring comprehensive treatment (including mental illness), and severe laboratory abnormalities.
  • Patients with a history of severe mental illness.
  • Pregnant or lactating women.
  • Patients who, in the opinion of the researchers, have other clinical or laboratory conditions that make them unsuitable for participation in the study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • The Sixth Affiliate Hospital of Sun Yat-Sen University — Guangzhou

Identifiers

NCT: NCT05797077 · 1010(PY)2022-10

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗