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NCT Number: NCT06631326

HAIC in Combination With PD-1 Inhibitors and Lenvatinib for High Tumor Burden Advanced HCC (CHANCE2416)

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 high tumor burden advanced-stage hepatocellular carcinoma (HCC) with portal vein tumor thrombus (PVTT).

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Key information

Conditions

HCC - Hepatocellular Carcinoma Adenocarcinoma BCLC Stage C Hepatocellular Carcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Hepatic Arterial Infusion Chemotherapy Lenvatinib Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial PD-1 Inhibitors

Age range

18 year–80 year

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

  • Age 18 to 80 years old;
  • Diagnosis of HCC was confirmed by histologic or cytologic analysis or clinical features according to the American Association for the Study of Liver Diseases (AASLD) guideline;
  • At least one measurable intrahepatic lesion as per the RECIST 1.1 criteria;
  • HCC staging of the patients are consistent with both the BCLC stage C and the CNLC stage IIIa.
  • Presence of PVTT;
  • Patients received a first-line lenvatinib+PD-1 (L+P) inhibitors combination or that of HAIC+lenvatinib+PD-1 inhibitors (H+L+P). More specifically, the administration of lenvatinib was concomitant with PD-1 inhibitors, and HAIC was performed either concurrently with, or up to 2 months before or after the L+P inhibitors combination therapy. Patients in the H+L+P group should undergo at least 2 cycles of HAIC, receive at least 2 cycles of PD-1 inhibiors and take at least 2 months of lenvatinib. Patients in the L+P group should receive at least 2 cycles of PD-1 inhibiors, and take at least 2 months of lenvatinib.
  • Child-Pugh class A or B7;
  • Tumor burden meets up to 7 out criteria.

Exclusion criteria

  • Patients who took anti-tumor treatments before the combination therapy;
  • With other malignant tumors;
  • incomplete data.

Treatment and study plan

hepatic artery infusion chemotherapy

Procedure

Hepatic arterial infusion chemotherapy including FOLFOX and RALOX

Lenvatinib + PD-1 monoclonal antibody

Drug

PD-1 inhibitors including Camrelizumab, Sintilimab, Tislelizumab

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) (Overall)

    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 mRECIST) or death due to any cause, whichever occurs first.

  2. Progression free survival(PFS) of intra-hepatic lesions

    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 of intra-hepatic lesions or death due to any cause, whichever occurs first.

  3. Progression free survival(PFS) of extra-hepatic lesions

    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 appearance of extra-hepatic lesions or death due to any cause, whichever occurs first.

  4. Progression free survival(PFS) of portal vein tumor thrombus (PVTT)

    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 of PVTT or death due to any cause, whichever occurs first.

  5. 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.

  6. ORR per mRECIST

    Time frame: Up to approximately 2 years

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

  7. 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.

  8. 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

Hepatic Arterial Infusion Chemotherapy Plus Lenvatinib and PD-1 Inhibitors Versus Lenvatinib Plus PD-1 Inhibitors as First-line Treatment for High Tumor Burden Advanced Hepatocellular Carcinoma With Portal Vein Tumor Thrombus: a Target Trial Emulation Study

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Oct 8, 2024
Registry last updated
Jan 27, 2026

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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