Maintenance therapy for colorectal cancer patients after liver surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to compare the effectiveness of a combination of adjuvant chemotherapy and maintenance therapy against adjuvant chemotherapy alone in patients with resectable liver metastases from colorectal cancer. The study focuses on patients who test positive for circulating tumor DNA (ctDNA) after surgery. By evaluating progression-free survival (PFS), the trial seeks to determine if the additional maintenance therapy can improve outcomes for these patients. The intervention includes colorectal resection surgery followed by the FOLFOX chemotherapy regimen and Capecitabine.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Both males and females, aged 18-75 years;
2. 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);
3. Postoperative ctDNA-positive patients;
4. ASA grade \< IV and/or ECOG performance status score ≤ 2;
5. Participants must have a full understanding of the study and voluntarily sign an informed consent form.

Exclusion Criteria:

1. Patients with distant metastases to other sites, including the pelvis, ovaries, peritoneum, etc.
2. Patients with a history of other malignant tumors.
3. Patients with severe liver or kidney dysfunction, cardiorespiratory dysfunction, coagulation dysfunction, or underlying diseases that cannot tolerate chemotherapy.
4. Patients who are allergic to any component of the study.
5. Patients who have received other tumor-related investigational drug treatments.
6. Patients with severe uncontrolled recurrent infections or other severe uncontrolled accompanying diseases.
7. 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.
8. Patients with a history of severe mental illness.
9. Pregnant or lactating women.
10. Patients who, in the opinion of the researchers, have other clinical or laboratory conditions that make them unsuitable for participation in the study.

Where it's running

• The Sixth Affiliate Hospital of Sun Yat-Sen University
  Guangzhou, Guangdong, China Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Evaluating a new immuno-adjuvant for colorectal liver metastases after ablation treatments

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• Testing immunotherapy combinations for colorectal cancer that has spread to the liver

  This study is testing different combinations of immunotherapy treatments for people with colorectal cancer that has spread to the liver to see if they can improve treatment results before surgery.

  Recruiting Phase 2 Weill Medical College of Cornell University · New York, New York · NCT06300463

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.