Treatment for colorectal cancer liver metastasis using combined therapies

A Study on the Efficacy and Safety of Multi-mode Ablation Combined With Systemic Therapy Including PD-1 Inhibitor in the Treatment of Colorectal Cancer Liver Metastasis(CRCLM)

This study is testing a new treatment combining a special procedure and medication for people with colorectal cancer that has spread to the liver and hasn't responded to earlier treatments.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Shanghai 6th People's Hospital (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Shanghai)
• Trial ID: NCT06590259 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with unresectable colorectal cancer liver metastasis who have failed first-line therapy.

Not a fit: Patients with resectable liver lesions or those who have not failed first-line treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a new treatment option for patients with difficult-to-treat colorectal cancer liver metastasis.

How similar studies have performed: While this approach is innovative, similar studies combining ablation with systemic therapies have shown promise, suggesting potential for success.

Eligibility criteria

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 this trial is running

Shanghai

• 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

Conditions Colorectal Cancer Liver Metastasis