HAIC in Combination with Immune Checkpoint Inhibitors and Tyrosine Kinase Inhibitors for Advanced HCC

N/AActive Not RecruitingNCT06632106

First Hospital of China Medical University97 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 different tumor burden advanced-stage hepatocellular carcinoma (HCC) with portal vein tumor thrombus (PVTT).

Study Type

OBSERVATIONAL

Enrollment

Conditions

Hepatic Arterial Infusion Chemotherapy Tyrosine Kinase Inhibitor Immune Checkpoint Inhibitors Hepatocellular Carcinoma (HCC)

Interventions

hepatic artery infusion chemotherapy

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 not received any previous systemic therapy for HCC (including chemotherapy, molecularly targeted therapy, immunotherapy); 4. Both TKIs and ICIs patients received only include marketed drugs but are not limited to HCC approval; 5. HAIC was performed after the first TKIs/ ICIs treatment or before treatment; 6. Received at least 2 cycles of HAIC or ICIs treatments； 7. Has repeated measurable intrahepatic lesions; 8. Child-Pugh class A or B. Exclusion Criteria: 1. Patients who took systemic anti-tumor treatments before the combination therapy; 2. With other malignant tumors; 3. Unable to meet criteria of combination timeframe described above.

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.