Treatment for colorectal cancer liver metastasis using combined therapies

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 study evaluates the efficacy and safety of a multi-mode ablation technique combined with systemic therapy, including a PD-1 inhibitor, for patients with colorectal cancer liver metastasis that is unresectable and has failed first-line treatment. It is a single-center, single-arm, prospective study involving 20 patients who will undergo ablation to achieve complete remission of liver lesions, followed by systemic therapy. The study aims to gather preliminary data on the treatment's effectiveness and safety, which could inform larger randomized trials in the future.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age 18-75 years, gender not specified;
2. Pathologically or clinically confirmed colorectal cancer liver metastases, with liver lesions unsuitable for surgical resection or intolerance or refusal of surgical resection;
3. In the case of an unresectable primary tumor or recurrence, the absence of serious complications such as bleeding or obstruction;
4. Failure of first-line treatment, with disease progression or new liver metastases;
5. No more than 5 liver lesions, with single lesion diameter ≤ 3cm;
6. For those who have received previous chemotherapy, radiotherapy or local liver treatment, the interval from the last systemic treatment or local liver treatment should be at least 1 month;
7. Child-Pugh A or B; bilirubin ≤ 3.0 mg/dL, creatinine ≤ 2.5 mg/dL, white blood cell count ≥ 2.0 ×10\^9/L, platelets ≥ 100 ×10\^9/L;
8. ECOG PS ≤ 2;
9. Willing to accept subsequent treatment regimens that include anti-PD-1 monoclonal antibody therapy.

Exclusion Criteria:

1. Liver function Child-Pugh class C;
2. Expected survival \< 3 months;
3. Major organ insufficiency or failure;
4. Active infection;
5. Irreversible coagulation disorders;
6. Refractory massive ascites, pleural effusion or cachexia;
7. Unable to cooperate with treatment;
8. Any other factors deemed inappropriate for inclusion or that may affect the subject's participation in the study, as determined by the investigator.

Where it's running

• Shanghai Sixth People's Hospital
  Shanghai, China Recruiting

Study contacts

• Principal investigator: Chief physician of Medical Oncology — Shanghai 6th People's Hospital
• Study coordinator: Chief physician of Medical Oncology
• Email: ssshenzan@163.com
• Phone: 13816067266

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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.