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

China Medical University

Status: Active, not recruiting

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

Treatments: Drug: Immune Checkpoint Inhibitors; Drug: Tyrosine kinase inhibitor (TKIs); Procedure: hepatic artery infusion chemotherapy

Study type: Observational

Funder types: Other

Identifiers

NCT06632106

NICER024

Details and patient eligibility

About

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).

Enrollment: 97 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

97 participants in 2 patient groups

HAIC plus TKIs and ICIs

Description:

Each patient should receive at least 2 cycles of HAIC and 1cycles of TKIs plus ICIs. The interval between HAIC and TKIs plus ICIs should be within 2 weeks.

Treatment:

Procedure: hepatic artery infusion chemotherapy

Drug: Tyrosine kinase inhibitor (TKIs)

Drug: Immune Checkpoint Inhibitors

TKIs plus ICIs

Description:

Each patient should receive at least 2 cycles of ICIs. The interval between TKIs and ICIs should be within 2 weeks.

Treatment:

Drug: Tyrosine kinase inhibitor (TKIs)

Drug: Immune Checkpoint Inhibitors