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

NCT ID: NCT06632093

Last Updated: 2024-10-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

84 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-09-16

Study Completion Date

2025-12-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

HAIC plus Lenvatinib and PD-1 inhibitors

Each patient should receive at least 2 cycles of HAIC and 1cycles of PD-1 plus Lenvatinib. The interval between HAIC and Lenvatinib plus PD-1 inhibitors should be within 2 weeks.

hepatic artery infusion chemotherapy

Intervention Type PROCEDURE

Hepatic arterial infusion chemotherapy including FOLFOX and RALOX

Lenvatinib + PD-1 monoclonal antibody

Intervention Type DRUG

PD-1 inhibitors including Camrelizumab, Sintilimab, Tislelizumab

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

hepatic artery infusion chemotherapy

Hepatic arterial infusion chemotherapy including FOLFOX and RALOX

Intervention Type PROCEDURE

Lenvatinib + PD-1 monoclonal antibody

PD-1 inhibitors including Camrelizumab, Sintilimab, Tislelizumab

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

First Hospital of China Medical University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Haibo Shao

Professor, MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The first hospital of China medical university

Shenyang, Liaoning, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Jiaxi Liu

Role: CONTACT

+8618940279150

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Haibo Shao

Role: primary

+8618940279150

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CHANCE2417

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.