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NCT Number: NCT06632106

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

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).

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Hepatic Arterial Infusion Chemotherapy Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Hepatocellular Carcinoma (HCC) Immune Checkpoint Inhibitors Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Tyrosine Kinase Inhibitor

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The first hospital of China medical university

Shenyang, Liaoning, 110000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

hepatic artery infusion chemotherapy

Procedure

Hepatic arterial infusion chemotherapy including FOLFOX and RALOX

Tyrosine kinase inhibitor (TKIs)

Drug

TKIs including Lenvatinib, Sorafenib, Apatinib, Donafenib, Bevacizumab

Immune Checkpoint Inhibitors

Drug

ICIs including Camrelizumab, Sintilimab, Tislelizumab, Pembrolizumab, Atezolizumab

Primary outcomes

  1. Overall survival (OS)

    Time frame: 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 outcomes

  1. Progression free survival(PFS)

    Time frame: 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.

  2. Objective response rate(ORR) per RESCIST 1.1

    Time frame: 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.

  3. ORR of PVTT

    Time frame: Up to approximately 2 years

    The ORR is defined as the proportion of patients with a documented CR or PR of PVTT.

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

First Hospital of China Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 8, 2024
Registry last updated
Oct 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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