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HAIC in Combination with PD-1 Inhibitors and Lenvatinib for High Tumor Burden Advanced HCC (CHANCE2416)

HAIC in Combination with PD-1 Inhibitors and Lenvatinib for High Tumor Burden Advanced HCC (CHANCE2416)

Recruiting
18-80 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 high tumor burden advanced-stage hepatocellular carcinoma (HCC) with portal vein tumor thrombus (PVTT).

Eligibility

Inclusion Criteria:

  1. Age 18 to 80 years old;
  2. Diagnosis of HCC was confirmed by histologic or cytologic analysis or clinical features according to the American Association for the Study of Liver Diseases (AASLD) guideline;
  3. At least one measurable intrahepatic lesion as per the RECIST 1.1 criteria;
  4. HCC staging of the patients are consistent with both the BCLC stage C and the CNLC stage IIIa.
  5. Presence of PVTT;
  6. Patients received a first-line lenvatinib+PD-1 (L+P) inhibitors combination or that of HAIC+lenvatinib+PD-1 inhibitors (H+L+P). More specifically, the administration of lenvatinib was concomitant with PD-1 inhibitors, and HAIC was performed either concurrently with, or up to 2 months before or after the L+P inhibitors combination therapy. Patients in the H+L+P group should undergo at least 2 cycles of HAIC, receive at least 2 cycles of PD-1 inhibiors and take at least 2 months of lenvatinib. Patients in the L+P group should receive at least 2 cycles of PD-1 inhibiors, and take at least 2 months of lenvatinib.
  7. Child-Pugh class A or B7;
  8. Tumor burden meets up to 7 out criteria.

Exclusion Criteria:

  1. Patients who took anti-tumor treatments before the combination therapy;
  2. With other malignant tumors;
  3. incomplete data.

Study details
    HCC - Hepatocellular Carcinoma
    Hepatic Arterial Infusion Chemotherapy
    BCLC Stage C Hepatocellular Carcinoma
    Lenvatinib
    PD-1 Inhibitors

NCT06631326

First Hospital of China Medical University

27 August 2025

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