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NCT Number: NCT05797077

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

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.

Recruiting

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Colorectal resection surgery.

Procedure

Colorectal cancer radical resection combined with liver metastasis resection or ablation.

FOLFOX chemotherapy regimen

Drug

Chemotherapy regimens recommended include oxaliplatin-based CapeOx or FOLFOX regimens, or single-agent 5-FU/LV, capecitabine, or combination with targeted therapy.

Other names: CapeOx chemotherapy regimen

Capecitabine

Drug

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.

Other names: 5-FU/LV

Primary outcomes

  1. 3-years Progression Free Survival

    Time frame: 3 years after operation.

    PFS is defined as the time from randomization to the occurrence of any progression or death from any cause.

  2. 5-years Progression Free Survival

    Time frame: 5 years after operation.

    PFS is defined as the time from randomization to the occurrence of any progression or death from any cause.

Secondary outcomes

  1. 3-years overall survival

    Time frame: 3 years after operation.

    Overall survival is defined as the time from randomization to death from any cause. For patients who are still alive at the time of the final analysis, the date of the last contact will be recorded.

  2. 5-years overall survival

    Time frame: 5 years after operation.

    Overall survival is defined as the time from randomization to death from any cause. For patients who are still alive at the time of the final analysis, the date of the last contact will be recorded.

  3. Complication

    Time frame: 5 years.

    he complications of adjuvant therapy usually refer to the adverse events that occur during or after treatment, including but not limited to chemotherapy-related adverse reactions, radiation therapy-related adverse reactions, and postoperative complications. Specifically, chemotherapy-related adverse reactions may include nausea, vomiting, diarrhea, anemia, and infections; radiation therapy-related adverse reactions may include skin inflammation, nausea, vomiting, diarrhea, fatigue, and dry mouth; postoperative complications may include bleeding, infection, intestinal obstruction, and poor wound healing. Researchers typically record the types, severity, and impact of these complications on treatment to evaluate the safety and tolerability of adjuvant therapy.

Sponsors and collaborators

Lead sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2029
Study completion
2031
First posted
Apr 4, 2023
Registry last updated
Apr 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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