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

First Hospital of China Medical University244 enrolled

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).

Study Type

OBSERVATIONAL

Enrollment

244

Conditions

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

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

The first hospital of China medical university

Shenyang, Liaoning, China

Outcomes

Primary Outcomes

Overall survival (OS)

The OS is defined as the time from the initiation of any combination treatment to death due to any cause.