Triple Therapy for Intermediate-advanced HCC With BDTT (TALENP002)

October 11, 2024 updated by: Mao-Lin Yan, Fujian Provincial Hospital

Transcatheter Arterial Chemoembolization Combined With Lenvatinib Plus Tislelizumab for Intermediate-advanced Hepatocellular Carcinoma With Bile Duct Tumor Thrombus: A Multicenter, Single-arm, Real-world Study

This is a multicenter, Single-arm, Real-world Study to evaluate the efficacy and safety of Transcatheter arterial chemoembolization (TACE), Lenvatinib combined with Tislelizumab (Triple Therapy) for patients with Hepatocellular Carcinoma (HCC) with bile duct tumor thrombus (BDTT).

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.

Detailed Description

Surgical resection is considered to be the treatment of choice for Hepatocellular Carcinoma (HCC) combined with bile duct tumor thrombus (BDTT), but a significant proportion of patients with HCC combined with BDTT are unable to undergo surgical treatment at the time of initial diagnosis. For patients with unresectable advanced HCC combined with BDTT, conversion therapy is particularly important. Currently, there is relatively little literature related to the conversion treatment of HCC with BDTT. Several studies have confirmed that the transcatheter arterial chemoembolization (TACE), lenvatinib, combined with Tislelizumab (Triple Therapy) for the treatment of intermediate-advanced HCC can achieve better efficacy with an acceptable safety. However, there are no clinical studies or relevant literature reports on Triple Therapy for the treatment of HCC with BDTT. The present study is a multicenter, Single-arm, Real-world Study designed to evaluate the efficacy and safety of a triple therapy for the treatment of patients with HCC with BDTT.

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.
20

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
    • Fujian
      • Fuzhou, Fujian, China
        • Recruiting
        • Fujian Provincial Hospital
        • Contact:
      • Fuzhou, Fujian, China, 350005
        • Not yet recruiting
        • First Affiliated Hospital of Fujian Medical University
        • Contact:
      • Fuzhou, Fujian, China, 350025
        • Not yet recruiting
        • Mengchao Hepatobiliary Hospital OF Fujian Medical University
        • Contact:
      • Xiamen, Fujian, China, 361005
        • Not yet recruiting
        • Zhongshan Hospital of Xiamen University
        • Contact:
      • Xiamen, Fujian, China, 361021
        • Not yet recruiting
        • First Affiliated Hospital of Xiamen University
        • Contact:
      • Zhangzhou, Fujian, China, 363099
        • Not yet recruiting
        • Zhangzhou Affiliated Hospital of Fujian 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

Non-Probability Sample

Study Population

Intermediate-advanced Hepatocellular Carcinoma With Bile Duct Tumor Thrombus

Description

Inclusion Criteria:

  1. Age between 18 and 75 years old;
  2. Patients with clinical diagnosis of Hepatocellular Carcinoma (HCC) combined with bile duct tumor thrombus (BDTT) (refer to the diagnostic criteria of the Chinese Expert Consensus on Multidisciplinary Diagnosis and Treatment of HCC with BDTT (2020 Edition)), BCLC Stage B or Stage C, and unresectable HCC (decided after multidisciplinary discussion);
  3. Patients who had not received any tumor-related targeted, immunotherapy, radiotherapy and chemotherapy before enrollment;
  4. Patients with at least one measurable lesion according to the mRECIST criteria (measurable lesion with a CT/MRI scan length diameter ≥ 10 mm and measurable lesion has not received localized treatment such as TACE, radiofrequency, cryotherapy, etc.);
  5. ECOG score: 0-1;
  6. liver function Child-Pugh class A or B; if combined with obstructive jaundice, total bilirubin ≤50umol/L is required. If higher than 50umol/L, biliary drainage is recommended;
  7. Blood routine: absolute neutrophil count ≥1.5×10^9/L, Hb≥8.5g/L, PLT≥75×10^9/L;
  8. No history of severe cardiac arrhythmia or heart failure; no history of severe ventilatory dysfunction or severe pulmonary infection; no acute or chronic renal failure with creatinine clearance >40mL/min;
  9. Expected survival time greater than 3 months.

Exclusion Criteria:

  1. The tumor with extrahepatic metastasis or invaded adjacent organs;
  2. Patients received other anti-tumor treatments;
  3. Existence of contraindications to TACE;
  4. History of allergy to the components or excipients of Lenvatinib or Tislelizumab;
  5. The patient has any active autoimmune disease or has an autoimmune disease with expected relapse. Patients are on immunosuppressive or systemic hormone therapy for immunosuppression;
  6. Patients with proteinuria suggestive of ≥ 1 + in routine urine will undergo a 24-hour urine protein test for patients with ≥ 1 g of 24-hour urine protein;
  7. Patients with co-morbidities of other malignant tumors;
  8. Patients with co-morbid psychiatric disorders;
  9. Patients with pregnant or lactating women;
  10. Patients with organ transplant patients;
  11. Patients with hypothyroidism or hyperthyroidism.

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.
Triple Therapy
Combination product: TACE, Lenvatinib, combined with Tislelizumab group
TACE, Lenvatinib [8mg(<60kg)/12mg(>60kg) orally daily] combination with Tislelizumab (200mg administered intravenous injection on Day 1 of each 21-day cycle). After the triple therapy, surgical resection is an option if assessed by the investigator to be feasible, or continued until disease progression or intolerable if not.

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
Objective response rate, ORR
Time Frame: Four weeks after the initiation of medication until the day before surgery
The Objective response rate (ORR) was defined as the complete response (CR) rate or the partial response (PR) rate according to mRECIST.
Four weeks after the initiation of medication until the day before surgery

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
Overall survival, OS
Time Frame: From date of enrollment until the date of death from any cause, assessed up to 60 months
The Overall survival (OS) was defined as the time between receiving treatment and observing death or loss of follow-up for any reason.
From date of enrollment until the date of death from any cause, assessed up to 60 months
Progression free survival, PFS
Time Frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
The Progression free survival (PFS) was defined as the time between the start of treatment and the progression of intrahepatic and/or extrahepatic tumors, or the occurrence of death or loss of follow-up for any reason.
From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
The Disease control rate, DCR
Time Frame: Four weeks after the initiation of medication until the day before surgery
The Disease control rate (DCR) was defined as the complete response (CR) rate or the partial response (PR) rate or stable disease (SD) rate according to mRECIST.
Four weeks after the initiation of medication until the day before surgery
Conversion resection rate, CRR
Time Frame: Four weeks after the initiation of medication until the day before surgery
The Conversion resection rate (CRR) was defined as the patient who reach the resectable criterion after treatment and accepted operation.
Four weeks after the initiation of medication until the day before surgery
Toxicity Adverse events
Time Frame: From the initiation of medication, with recordings made whenever an adverse reaction occurs, assessed up to 12 months
Grade 1-5 AEs according to NCI-CTCAE V5.0.
From the initiation of medication, with recordings made whenever an adverse reaction occurs, assessed up to 12 months

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.
Fujian Provincial 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.
September 30, 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.
July 1, 2027

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.
October 1, 2028

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).
September 17, 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.
September 17, 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.
September 19, 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 15, 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 11, 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.
  • TALENP002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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Conditions

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