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

RECRUITING

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

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

NCT06632093•First Hospital of China Medical University

View on ClinicalTrials.gov

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

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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

Exclusion Criteria

•1. The interval between the failure of systemic therapy and the beginning of combination therapy longer than 3 months;
•2. With other malignant tumors;
•3. Unable to meet criteria of combination timeframe described above.

Locations (1)

The first hospital of China medical university

Shenyang, Liaoning, China

Key Dates

Start Date

September 16, 2024

Primary Completion Date

September 30, 2025

Completion Date

December 30, 2025

Last Updated

October 8, 2024

Enrollment

ESTIMATED participants

Conditions

BCLC Stage B Hepatocellular CarcinomaBCLC Stage C Hepatocellular CarcinomaHepatic Arterial Infusion ChemotherapyLenvatinibPD-1Systemic Therapy

Interventions

hepatic artery infusion chemotherapy

PROCEDURE

Lenvatinib + PD-1 monoclonal antibody

DRUG

Contacts

Jiaxi Liu

CONTACT

+8618940279150 dmuvictor@163.com

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COMPLETED

Using Machine Learning to Identify Responders to TACE or HAIC for uHCC

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 8, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Real-World Treatment Patterns and Survival Outcomes in Patients With Intermediate-Stage Hepatocellular Carcinoma.

Using Machine Learning to Identify Responders to TACE or HAIC for uHCC

Effect of Esketamine on Abdominal Pain During TACE-HAIC in Patients With Hepatocellular Carcinoma