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

Recruiting

Conditions

Intervention / Treatment

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

Observational

Enrollment (Estimated)

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 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

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
Intervention / Treatment
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

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

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

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)

September 30, 2024

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

October 1, 2028

Study Registration Dates

First Submitted

September 17, 2024

First Submitted That Met QC Criteria

September 17, 2024

First Posted (Actual)

September 19, 2024

Study Record Updates

Last Update Posted (Actual)

October 15, 2024

Last Update Submitted That Met QC Criteria

October 11, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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