TACE Plus Multikinase Inhibitor and I-125 Seeds Brachytherapy for HCC With Branch PVTT

May 16, 2023 updated by: Second Affiliated Hospital of Guangzhou Medical University

Transarterial Chemoembolization Combined With Lenvatinib and Iodion-125 Seeds Brachytherapy for Hepatocellular Carcinoma With Portal Vein Branch Tumor Thrombus: a Single Center, Prospective, Randomized Control Trail

This study is conducted to evaluate the efficacy and safety of transarterial chemoembolization (TACE) combined with lenvatinib and iodion-125 seeds brachytherapy (TACE-Len-I) compared with TACE combined with lenvatinib (TACE-Len) for hepatocellular carcinoma (HCC) with portal vein branch tumor thrombus (branch PVTT).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is an single center, randomized controlled trial to evaluate the efficacy and safety of TACE-Len-I compared with TACE-Len for the treatment of HCC with branch PVTT.

171 HCC patients with branch PVTT will be enrolled in this study. The Patients will be treated with TACE-Len-I or TACE-Len using an 2:1 randomization scheme.

TACE will be performed for the patients after randomization. Lenvatinib (body weight ≥ 60 kg, 12mg P.O. QD; body weight < 60 kg, 8mg P.O. QD) will be started at 3-7 days after the first TACE and last until disease progresses, intolerable toxicity, withdrawal of informed consent, loss of follow-up, death, or other circumstances that require termination of treatment, whichever occurs first. For patients in the TACE-Len-I arm, iodion-125 seeds will be implanted into the PVTT (according to the pre-operative planning) under CT guidance within 14 days after the first TACE. TACE and iodion-125 seeds implantation can be repeated on demand during follow-up based on the evaluation of laboratory and imaging examination.

Study Type

Interventional

Enrollment (Anticipated)

171

Phase

  • Not Applicable

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

  • Name: Mingyue Cai, Dr.
  • Phone Number: +86-20-34156205
  • Email: cai020@yeah.net

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510260
        • Recruiting
        • The Second Affiliated Hospital of Guangzhou 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

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age between18 and 75 years.
  2. HCC confirmed by histopathology and/or cytology, or diagnosed clinically.
  3. Accompanied with tumor thrombus involving unilateral portal vein branch.
  4. Child-Pugh class A or B.
  5. Eastern Cooperative Group performance status (ECOG) score of 0-2.
  6. Serum bilirubin ≤ 51.3 μmol/L, albumin ≥ 28g/L, ALT and AST ≤ 5 times of the upper normal limit, and creatinine ≤ 20g/L.
  7. Prothrombin time prolonged for less than 4s or international normalized ratio < 1.7.
  8. Neutrophilic granulocyte count ≥ 1.5×10^9/L, platelet count ≥ 50×10^9/L, and hemoglobin level ≥ 85g/L;
  9. At least one measurable intrahepatic target lesion.
  10. Life expectancy of at least 3 months.

Exclusion Criteria:

  1. Diffuse HCC.
  2. Extrahepatic metastasis.
  3. Tumor thrombus involving both the left and right branch of portal vein or main portal vein.
  4. Hepatic vein and/or vena cava invasion.
  5. History of organ or cells transplantation.
  6. Previous treatment with TACE, intra-arterial infusion chemotherapy, radiotherapy or systemic therapy.
  7. History of other malignancies.
  8. Serious medical comorbidities.
  9. Female patients who are pregnancy or breastfeeding.

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TACE-Len-I
TACE combined with lenvatinib and iodion-125 seeds brachytherapy
Procedure: TACE combined with lenvatinib and iodion-125 seeds brachytherapy
TACE will be performed for the patients after randomization. Lenvatinib (body weight ≥ 60 kg, 12mg P.O. QD; body weight < 60 kg, 8mg P.O. QD) will be started at 3-7 days after the first TACE and last until disease progresses, intolerable toxicity, withdrawal of informed consent, loss of follow-up, death, or other circumstances that require termination of treatment, whichever occurs first. Iodion-125 seeds will be implanted into the PVTT under CT guidance within 14 days after the first TACE. TACE and iodion-125 seeds implantation can be repeated on demand during follow-up based on the evaluation of laboratory and imaging examination.
Active Comparator: TACE-Len
TACE combined with lenvatinib
Procedure: TACE combined with lenvatinib
TACE will be performed for the patients after randomization and it can be repeated on demand during follow-up based on the evaluation of laboratory and imaging examination. Lenvatinib (body weight ≥ 60 kg, 12mg P.O. QD; body weight < 60 kg, 8mg P.O. QD) will be started at 3-7 days after the first TACE and last until disease progresses, intolerable toxicity, withdrawal of informed consent, loss of follow-up, death, or other circumstances that require termination of treatment, whichever occurs first.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: 2 years.
The time from date of randomization to death due to any cause.
2 years.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events (AEs)
Time Frame: 2 years.
Number of patients with AE, treatment-related AE (TRAE), AE of special interest (AESI), serious adverse event (SAE), assessed by NCI CTCAE v5.0.
2 years.
Progression free survival (PFS) assessed by investigators according to Modified Response Evalutaion Criteria in Solid Tumors (mRECIST)
Time Frame: 2 years.
The time from date of randomization until the first occurrence of disease progression (PD) or death due to any cause, whichever occurs first.
2 years.
Objective response rate (ORR) assessed by investigators according to mRECIST
Time Frame: 2 years.
The percentage of patients who had a best overall tumor response rating of complete response (CR) or partial response (PR).
2 years.
Disease control rate (DCR) assessed by investigators according to mRECIST
Time Frame: 2 years.
The percentage of patients who had a tumor response rating of CR, PR, or stable disease (SD).
2 years.
Duration of portal patency
Time Frame: 2 years.
The time from randomization until the date that complete portal vein occlusion was confirmed.
2 years.

Collaborators and Investigators

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

Sponsor

Second Affiliated Hospital of Guangzhou 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)

July 9, 2021

Primary Completion (Anticipated)

January 8, 2025

Study Completion (Anticipated)

January 8, 2025

Study Registration Dates

First Submitted

July 8, 2021

First Submitted That Met QC Criteria

July 8, 2021

First Posted (Actual)

July 19, 2021

Study Record Updates

Last Update Posted (Actual)

May 18, 2023

Last Update Submitted That Met QC Criteria

May 16, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MIIR-07

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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