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

Launched by SHANGHAI 6TH PEOPLE'S HOSPITAL · Sep 9, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with colorectal cancer that has spread to the liver, known as colorectal cancer liver metastasis (CRCLM). The researchers want to find out if combining a special procedure called multi-mode ablation with a systemic therapy (which includes a type of treatment that helps the immune system fight cancer) is effective and safe. They will also compare immune indicators before and after the treatment to better understand its benefits.

To participate in this trial, you must be between 18 and 75 years old and have confirmed colorectal cancer liver metastases that cannot be surgically removed. You should have already tried first-line treatments without success, and your liver health must be stable. Participants should be willing to receive a treatment that includes an anti-PD-1 medication, which helps enhance the body's immune response. If you join the trial, you will receive this new treatment approach and be closely monitored for safety and effectiveness throughout the study.

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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.