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

NCT06632106 | Active Not Recruiting

• 1 other identifier: NICER024
• Study Type: observational
• Target: 97
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Progression free survival(PFS)

  Up to approximately 2 years

• Objective response rate(ORR) per RESCIST 1.1

  Up to approximately 2 years

• ORR of PVTT

  Up to approximately 2 years

• Adverse event(AE) per Common Terminology Criteria for Adverse Events(CTCAE) 5.0

  Up to approximately 2 years

Study Arms (2)

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; Drug: Tyrosine kinase inhibitor (TKIs); Drug: Immune Checkpoint Inhibitors

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); Drug: Immune Checkpoint Inhibitors

Interventions

hepatic artery infusion chemotherapy PROCEDURE

Hepatic arterial infusion chemotherapy including FOLFOX and RALOX

HAIC plus TKIs and ICIs

Tyrosine kinase inhibitor (TKIs) DRUG

TKIs including Lenvatinib, Sorafenib, Apatinib, Donafenib, Bevacizumab

HAIC plus TKIs and ICIs; TKIs plus ICIs

Immune Checkpoint Inhibitors DRUG

ICIs including Camrelizumab, Sintilimab, Tislelizumab, Pembrolizumab, Atezolizumab

HAIC plus TKIs and ICIs; TKIs plus ICIs

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Has a diagnosis of HCC confirmed by radiology, histology, or cytology;
• Barcelona Clinic Liver Cancer (BCLC) stage C with the presence of portal vein tumor thrombus;
• Has not received any previous systemic therapy for HCC (including chemotherapy, molecularly targeted therapy, immunotherapy);
• Both TKIs and ICIs patients received only include marketed drugs but are not limited to HCC approval;
• HAIC was performed after the first TKIs/ ICIs treatment or before treatment;
• Received at least 2 cycles of HAIC or ICIs treatments；
• Has repeated measurable intrahepatic lesions;
• Child-Pugh class A or B.

You may not qualify if:

• Patients who took systemic anti-tumor treatments before the combination therapy;
• With other malignant tumors;
• Unable to meet criteria of combination timeframe described above.

Sponsors & Collaborators

• First Hospital of China Medical University: lead

Study Sites (1)

The first hospital of China medical university

Shenyang, Liaoning, 110000, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Tyrosine Kinase Inhibitors; Immune Checkpoint Inhibitors

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Protein Kinase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD, PhD

Study Record Dates

• First Submitted: October 6, 2024
• First Posted: October 8, 2024
• Study Start: August 16, 2024
• Primary Completion: January 30, 2025
• Study Completion: May 30, 2025
• Last Updated: October 8, 2024

Record last verified: 2024-10

Locations

CN (1)