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

October 6, 2024 updated by: Haibo Shao, First Hospital of China Medical University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
84

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Liaoning
      • Shenyang, Liaoning, China, 110000
        • Recruiting
        • The First Hospital of China Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients with intermediate or advanced HCC who have failed in systemic therapy recommended by BCLC and received HAIC in combination with PD-1 inhibitors and Lenvatinib under real-world practice conditions.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Procedure: hepatic artery infusion chemotherapy
Hepatic arterial infusion chemotherapy including FOLFOX and RALOX
Drug: Lenvatinib + PD-1 monoclonal antibody
PD-1 inhibitors including Camrelizumab, Sintilimab, Tislelizumab

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Up to approximately 2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Up to approximately 2 years
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.
Up to approximately 2 years
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.
Up to approximately 2 years
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.
Up to approximately 2 years
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.
Up to approximately 2 years
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.
Up to approximately 2 years
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.
Up to approximately 2 years
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.
Up to approximately 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
First Hospital of China Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 16, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 6, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 6, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 8, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 8, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 6, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CHANCE2417

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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