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A Study on the Efficacy and Safety of Multi-mode Ablation Combined With Systemic Therapy in the Treatment of CRCLM

A Study on the Efficacy and Safety of Multi-mode Ablation Combined With Systemic Therapy in the Treatment of CRCLM

Recruiting
18-75 years
All
Phase 2

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Overview

The goal of this study is to evaluate the efficacy and safety of multi-mode ablation combined with systemic therapy including PD-1(programmed death receptor 1) inhibitor for colorectal cancer liver metastasis and furthermore to clarify its application value by comparing preoperative and postoperative immune indicators.

Description

This is a single-center, single-arm, prospective study to evaluate the efficacy and safety of multi-mode ablation combined with systemic therapy including PD-1 inhibitor in the treatment of colorectal cancer liver metastasis. The study includes 20 patients with colorectal cancer liver metastasis that has failed first-line therapy and is unresectable. All patients will receive multi-mode ablation to achieve complete remission of liver lesions followed by systemic therapy including PD-1 inhibitor.

This study will provide preliminary data 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, which could lead to larger randomized trials.

Eligibility

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.

Study details
    Colorectal Cancer Liver Metastasis

NCT06590259

Shanghai 6th People's Hospital

21 August 2025

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