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Recruiting NCT06632093

HAIC in Combination with PD-1 Inhibitors and Lenvatinib for Intermediate and Advanced HCC After the Failure of Systemic Therapy Recommended by BCLC

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Trial Parameters

Condition BCLC Stage B Hepatocellular Carcinoma
Sponsor First Hospital of China Medical University
Study Type OBSERVATIONAL
Phase N/A
Enrollment 84
Sex ALL
Min Age 18 Years
Max Age 75 Years
Start Date 2024-09-16
Completion 2025-09-30
Interventions
hepatic artery infusion chemotherapyLenvatinib + PD-1 monoclonal antibody

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Brief Summary

The purpose of this study is to evaluate the safety and efficacy of hepatic arterial infusion chemotherapy (HAIC) in combination with PD-1 inhibitors and Lenvatinib in patients with intermediate or advanced-stage hepatocellular carcinoma (HCC) after failure of systemic therapy recommended by BCLC.

Eligibility Criteria

Inclusion Criteria: 1. Has a diagnosis of HCC confirmed by radiology, histology, or cytology; 2. Barcelona Clinic Liver Cancer (BCLC) stage C with the presence of portal vein tumor thrombus; 3. Has received previous systemic therapy recommended for HCC by BCLC, and the systemic therapy failed; 4. Both PD-1inhibitors and Lenvatinib patients received only include marketed drugs but are not limited to HCC approval; 5. HAIC was performed after the first PD-1 inhibitor/ Lenvatinib treatment or before treatment; 6. Received at least 2 cycles of HAIC; 7. Has repeated measurable intrahepatic lesions; 8. Child-Pugh class A or B. Exclusion Criteria: 1. The interval between the failure of systemic therapy and the beginning of combination therapy longer than 3 months; 2. With other malignant tumors; 3. Unable to meet criteria of combination timeframe described above.

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