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

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

Recruiting
18-75 years
All
Phase N/A

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Overview

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

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.

Study details
    BCLC Stage B Hepatocellular Carcinoma
    BCLC Stage C Hepatocellular Carcinoma
    Hepatic Arterial Infusion Chemotherapy
    Lenvatinib
    PD-1
    Systemic Therapy

NCT06632093

First Hospital of China Medical University

15 October 2025

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