TACE Combined With ICIs Plus MTT After 125I Irradiation Stent Placement in HCC With Main PVTT.

October 31, 2024 updated by: Gao-jun Teng, Zhongda Hospital

Transcatheter Arterial Chemoembolization Combined With ICIs Plus MTT After Irradiation Stent Placement in HCC With Main PVTT: a Multicenter Propensity Score Matching Study

Hepatocellular carcinoma (HCC) patients with Vp4 [main trunk] portal vein tumor thrombosis (PVTT) face a significantly poor prognosis, and current treatment options provide limited benefits. We aimed to assess the safety and efficacy of transcatheter arterial chemoembolization (TACE) combined with immune checkpoint inhibitors (ICIs) plus molecular targeted therapy (MTT) after irradiation stent placement (ISP) as first line treatment for HCC patients with Vp4 PVTT.

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.

Detailed Description

According to the latest report, liver cancer is the third leading cause of cancer-related deaths, following lung and colorectal cancers, with hepatocellular carcinoma (HCC) accounting for 75% to 85% of all primary liver cancer cases. Portal vein tumor thrombosis (PVTT) is a significant indicator of poor prognosis in HCC, with a high incidence of 39-63% and a median survival of 2.7 months.

Systemic therapy is the recommended treatment for HCC patients with Vp4 [main trunk] portal vein tumor thrombus (PVTT). The landmark IMbrave150 study has ushered in a new era of combined systemic therapy for patients with unresectable HCC. However, subgroup analysis indicates that overall survival (OS) for HCC patients with Vp4 PVTT remains poor in both the sorafenib (5.5 months) or atezolizumab plus bevacizumab (7.6 months) groups.

Recent studies indicate that incorporating transcatheter arterial chemoembolization (TACE) significantly benefits HCC patients compared to systemic therapy alone, with significantly prolonged OS and progression free survival (PFS). However, HCC with PVTT is generally considered a contraindication to transcatheter arterial chemoembolization (TACE). When the portal vein blood supply has been damaged, TACE may lead to the reduction or even interruption of hepatic artery and the exacerbate the deterioration of liver function, eventually leading to liver failure. Although a few studies have explored TACE treatment in patients with Vp3-4 PVTT, the results have not shown a significant extension in survival.

Iodine-125 (125I) irradiation stent placement (ISP) can quickly restore blood flow and alleviate portal hypertension caused by tumor thrombus. Moreover, compared to bare stents, irradiation stents offer a uniform and sustained radiation distribution to PVTT, thus ensuring long-term patency of the portal vein and enabling the possibility of TACE for HCC patients with Vp4 PVTT. Our previous randomized controlled trial has demonstrated the safety and efficacy of ISP combined with TACE.

Herein, this nationwide multicenter, retrospective, propensity score matching (PSM) cohort study (PATENCYⅡ) aims to assess the safety and efficacy of immune checkpoint inhibitors (ICIs) plus molecular targeted therapy (MTT) with or without ISP plus TACE as first line treatment for HCC patients with Vp4 PVTT.

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.
444

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 Contact Backup

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210009
        • Recruiting
        • Zhongda hospital
        • 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 HCC and Vp4 PVTT who received TACE in combination with PD-1/PD-L1 inhibitors and molecular target therapies after 125I irradiation stent placement under real-world practice conditions

Description

Inclusion Criteria:

  1. age ≥18 years old; (2) diagnosis of HCC is confirmed through histological or cytological analysis, as well as clinical features; (3) histologically confirmed or imaging-diagnosed PVTT extending to the main portal vein (Vp4); (4) including at least one measurable intrahepatic lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1; (5) Eastern Cooperative Oncology Group (ECOG) performance status of ≤2; (6) patients received first-line treatment with either ICIs-MTT or an ISP-containing quadruple combination within eight weeks (In the ICIs-MTT group, MTT was administered alongside ICIs. In the ISP-containing quadruple, TIT and ICIs-MTT were given after stent placement and portal vein recanalization, either simultaneously or within eight weeks before or after the ICIs-MTT therapy).

Exclusion Criteria:

  1. patients with extrahepatic metastases; (2) a history of or concurrent malignancies; (3) patients underwent prior systemic treatments or locoregional therapies, including surgery, radiation therapy, hepatic arterial embolization, TACE, hepatic arterial infusion, radiofrequency ablation, percutaneous ethanol injection, and cryoablation, within three months before the initiation of ISP.; (4) Child-Pugh grade C liver function, a Child-Pugh score of 3 for ascites, or the presence of overt hepatic encephalopathy; (5) incomplete outcome data or missing essential baseline factors for analysis.

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

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 (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.
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
Progression free survival(PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
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 RECIST 1.1) or death due to any cause, whichever occurs first.
up to approximately 2 years
PFS per Modified Response Evaluation Criteria in Solid Tumors (mRECIST)
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
Disease Control Rate (DCR) per RESCIST 1.1
Time Frame: up to approximately 2 years
DCR is defined as the percentage of participants who have a best overall response of CR, PR, or stable disease (SD)per RESCIST 1.1.
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
Disease Control Rate (DCR) per mRECIST
Time Frame: up to approximately 2 years
DCR is defined as the percentage of participants who have a best overall response of CR, PR, or stable disease (SD) per mRECIST.
up to approximately 2 years
Objective response rate(ORR) of intrahepatic lesions and portal vein tumor thrombosis (PVTT) 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
Objective response rate(ORR) of intrahepatic lesions and portal vein tumor thrombosis (PVTT) 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
Hepatic function
Time Frame: up to approximately 2 years
Hepatic function was measured in terms of total bilirubin, albumin, aspartate transaminase, alanine aminotransferase, alkaline phosphatase, prothrombin time
up to approximately 2 years
Patency of portal vein
Time Frame: up to approximately 2 years
Patency of portal vein was evaluated by color doppler ultrasound
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.
Zhongda Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Gaojun Teng, M.D., Zhongda hospital

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.
January 1, 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.
January 31, 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.
March 31, 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 31, 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 31, 2024

First Posted (Estimated)

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.
November 1, 2024

Study Record Updates

Last Update Posted (Estimated)

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.
November 1, 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 31, 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

Keywords

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.
  • PATENCY2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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