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

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 Overview

• Status: Active, not recruiting
• Conditions: Hepatocellular Carcinoma (HCC); Immune Checkpoint Inhibitors; Tyrosine Kinase Inhibitor; Hepatic Arterial Infusion Chemotherapy
• Intervention / Treatment: Procedure: hepatic artery infusion chemotherapy; Drug: Tyrosine kinase inhibitor (TKIs); Drug: Immune Checkpoint Inhibitors

• Study Type: Observational
• Enrollment (Actual): 97

Contacts and Locations

Study Locations

• China
  • Liaoning
    • Shenyang, Liaoning, China, 110000
      • The First Hospital of China Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with advanced HCC with PVTT who received HAIC in combination with TKIs and ICIs under real-world practice conditions.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
HAIC plus TKIs and ICIs; 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.	Procedure: hepatic artery infusion chemotherapy; Hepatic arterial infusion chemotherapy including FOLFOX and RALOX; Drug: Tyrosine kinase inhibitor (TKIs); TKIs including Lenvatinib, Sorafenib, Apatinib, Donafenib, Bevacizumab; Drug: Immune Checkpoint Inhibitors; ICIs including Camrelizumab, Sintilimab, Tislelizumab, Pembrolizumab, Atezolizumab
TKIs plus ICIs; Each patient should receive at least 2 cycles of ICIs. The interval between TKIs and ICIs should be within 2 weeks.	Drug: Tyrosine kinase inhibitor (TKIs); TKIs including Lenvatinib, Sorafenib, Apatinib, Donafenib, Bevacizumab; Drug: Immune Checkpoint Inhibitors; ICIs including Camrelizumab, Sintilimab, Tislelizumab, Pembrolizumab, Atezolizumab

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression free survival(PFS)	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.	Up to approximately 2 years
Objective response rate(ORR) per RESCIST 1.1	The ORR is defined as the proportion of patients with a documented complete response(CR) or partial response(PR) per RECIST 1.1.	Up to approximately 2 years
ORR of PVTT	The ORR is defined as the proportion of patients with a documented CR or PR of PVTT.	Up to approximately 2 years
Adverse event(AE) per Common Terminology Criteria for Adverse Events(CTCAE) 5.0	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.	Up to approximately 2 years

Collaborators and Investigators

• Sponsor: First Hospital of China Medical University

Study record dates

Study Major Dates

• Study Start (Actual): August 16, 2024
• Primary Completion (Estimated): January 30, 2025
• Study Completion (Estimated): May 30, 2025

Study Registration Dates

• First Submitted: October 6, 2024
• First Submitted That Met QC Criteria: October 6, 2024
• First Posted (Actual): October 8, 2024

Study Record Updates

• Last Update Posted (Actual): October 8, 2024
• Last Update Submitted That Met QC Criteria: October 6, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Antineoplastic Agents, Immunological; Protein Kinase Inhibitors; Immune Checkpoint Inhibitors; Tyrosine Kinase Inhibitors
• Other Study ID Numbers: NICER024

Drug and device information, study documents

• product manufactured in and exported from the U.S.: No