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NCT Number: NCT06632093

HAIC in Combination with PD-1 Inhibitors and Lenvatinib for Intermediate and Advanced HCC After the Failure of Systemic Therapy Recommended by BCLC

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 intermediate or advanced-stage hepatocellular carcinoma (HCC) after failure of systemic therapy recommended by BCLC.

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Key information

Conditions

BCLC Stage B Hepatocellular Carcinoma BCLC Stage C Hepatocellular Carcinoma Hepatic Arterial Infusion Chemotherapy Lenvatinib PD-1 Systemic Therapy

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The first hospital of China medical university

Shenyang, Liaoning, 110000, China

Location status: Recruiting

Location contact

Haibo Shao

CONTACT

[email protected]

+8618940279150

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 received previous systemic therapy recommended for HCC by BCLC, and the systemic therapy failed;
  • Both PD-1inhibitors and Lenvatinib patients received only include marketed drugs but are not limited to HCC approval;
  • HAIC was performed after the first PD-1 inhibitor/ Lenvatinib treatment or before treatment;
  • Received at least 2 cycles of HAIC；
  • Has repeated measurable intrahepatic lesions;
  • Child-Pugh class A or B.

Exclusion criteria

  • The interval between the failure of systemic therapy and the beginning of combination therapy longer than 3 months;
  • 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

Lenvatinib + PD-1 monoclonal antibody

Drug

PD-1 inhibitors including Camrelizumab, Sintilimab, Tislelizumab

Primary outcomes

  1. Overall survival

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jiaxi Liu

CONTACT

[email protected]

+8618940279150

Sponsors and collaborators

Lead sponsor

First Hospital of China Medical University

Other

Registry information

Official study title

Hepatic Arterial Infusion Chemotherapy in Combination with PD-1 Inhibitors and Lenvatinib for Intermediate and Advanced Hepatocellular Carcinoma After the Failure of Systemic Therapy Recommended by BCLC

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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