Comparing chemotherapy and observation for liver metastasis in colorectal cancer

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 evaluate whether a 'watching and waiting' approach is as effective as adjuvant chemotherapy for patients with resectable colorectal cancer liver metastases who test negative for circulating tumor DNA (ctDNA) after surgery. Participants will be randomly assigned to either receive the FOLFOX chemotherapy regimen or to be monitored without immediate treatment. The primary outcome measured will be the 3-year progression-free survival rate between the two groups. This study seeks to determine if avoiding chemotherapy is a viable option for certain patients post-surgery.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Both genders are eligible; aged between 18-75 years old; have received neoadjuvant chemotherapy;
2. Patients with liver metastatic colorectal cancer who have achieved R0 resection according to MDT evaluation (including patients with metastases treated with ablation therapy that achieved similar R0 resection effects);
3. Patients with negative ctDNA after surgery;
4. ASA grade \<IV and/or ECOG performance status score ≤ 2;
5. Have sufficient understanding of the study and voluntarily sign an informed consent form.

Exclusion Criteria:

1. Patients with distant metastases, including pelvic, ovarian, peritoneal, etc.;
2. Patients with a history of other malignancies;
3. Patients with severe liver, kidney, heart and lung dysfunction, coagulation dysfunction, or serious underlying diseases who cannot tolerate chemotherapy;
4. Patients who are allergic to any component in the study;
5. Patients who have received other tumor-related investigational drug therapy;
6. Patients with severe uncontrolled recurrent infections or other serious uncontrolled concurrent diseases;
7. Patients with other factors that may affect the study results or lead to premature termination of the study, such as alcoholism, drug abuse, other serious diseases that require comprehensive treatment (including mental disorders), and serious abnormal laboratory tests;
8. Patients with a history of severe mental illness;
9. Pregnant or lactating women;
10. Patients with other clinical or laboratory conditions that the investigator deems unsuitable for participation in the trial.

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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• Combining radiation therapy and PD-1 antibody for liver metastases from colorectal cancer

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

  This study is testing a new treatment called IP-001 to see if it can boost the immune response and help people with colorectal liver metastases feel better after they have undergone ablation therapies.

  Recruiting Phase 1/2 Amsterdam UMC, location VUmc · Amsterdam, North Holland · NCT06630624

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.