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

In Which Tumor Burden Range Does Advanced Hepatocellular Carcinoma Patients Benefit More from Hepatic Arterial Infusion Chemotherapy Plus Immune Checkpoint Inhibitors and Tyrosine Kinase Inhibitors Than Immune Checkpoint Inhibitors Plus Tyrosine Kinase Inhibitors? a Multi-center, Retrospective, Propensity Score Matching Study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06632106

Enrollment

Registered

2024-10-08

Start date

2024-08-16

Completion date

2025-05-30

Last updated

2024-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief summary

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).

Interventions

PROCEDUREhepatic artery infusion chemotherapy

Hepatic arterial infusion chemotherapy including FOLFOX and RALOX

DRUGTyrosine kinase inhibitor (TKIs)

TKIs including Lenvatinib, Sorafenib, Apatinib, Donafenib, Bevacizumab

DRUGImmune Checkpoint Inhibitors

ICIs including Camrelizumab, Sintilimab, Tislelizumab, Pembrolizumab, Atezolizumab

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
Overall survival (OS)	Up to approximately 2 years	The OS is defined as the time from the initiation of any combination treatment to death due to any cause.

Secondary

Measure	Time frame	Description
Objective response rate(ORR) per RESCIST 1.1	Up to approximately 2 years	The ORR is defined as the proportion of patients with a documented complete response(CR) or partial response(PR) per RECIST 1.1.
ORR of PVTT	Up to approximately 2 years	The ORR is defined as the proportion of patients with a documented CR or PR of PVTT.
Adverse event(AE) per Common Terminology Criteria for Adverse Events(CTCAE) 5.0	Up to approximately 2 years	The percentage and degree of patients who experience at least one AE, whether or not considered related to the treatment, according to CTCAE version 5.0.
Progression free survival(PFS)	Up to approximately 2 years	The PFS is defined as the time from the initiation of any combination treatment to the first documented progressive disease (according to RECIST1.1) or death due to any cause, whichever occurs first.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026