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

Primary Purpose

Hepatocellular Carcinoma Non-resectable

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

TACE combined with lenvatinib and iodion-125 seeds brachytherapy

TACE combined with lenvatinib

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma Non-resectable focused on measuring Hepatocellular Carcinoma, Transarterial chemoembolization, Tyrosine kinase inhibitor, iodion-125 seed

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

the Second Affiliated Hospital of Guangzhou Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

TACE-Len-I

TACE-Len

Arm Description

TACE combined with lenvatinib and iodion-125 seeds brachytherapy

TACE combined with lenvatinib

Outcomes

Primary Outcome Measures

Overall survival (OS)

The time from date of randomization to death due to any cause.

Secondary Outcome Measures

Adverse events (AEs)

Number of patients with AE, treatment-related AE (TRAE), AE of special interest (AESI), serious adverse event (SAE), assessed by NCI CTCAE v5.0.

Progression free survival (PFS) assessed by investigators according to Modified Response Evalutaion Criteria in Solid Tumors (mRECIST)

The time from date of randomization until the first occurrence of disease progression (PD) or death due to any cause, whichever occurs first.

Objective response rate (ORR) assessed by investigators according to mRECIST

The percentage of patients who had a best overall tumor response rating of complete response (CR) or partial response (PR).

Disease control rate (DCR) assessed by investigators according to mRECIST

The percentage of patients who had a tumor response rating of CR, PR, or stable disease (SD).

Duration of portal patency

The time from randomization until the date that complete portal vein occlusion was confirmed.

Full Information

NCT ID

NCT04967495

First Posted

July 8, 2021

Last Updated

May 16, 2023

Sponsor

Second Affiliated Hospital of Guangzhou Medical University

1. Study Identification

Unique Protocol Identification Number

NCT04967495

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

July 9, 2021 (Actual)

Primary Completion Date

January 8, 2025 (Anticipated)

Study Completion Date

January 8, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Second Affiliated Hospital of Guangzhou Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatocellular Carcinoma Non-resectable

Keywords

Hepatocellular Carcinoma, Transarterial chemoembolization, Tyrosine kinase inhibitor, iodion-125 seed

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

171 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

TACE-Len-I

Arm Type

Experimental

Arm Description

TACE combined with lenvatinib and iodion-125 seeds brachytherapy

Arm Title

TACE-Len

Arm Type

Active Comparator

Arm Description

TACE combined with lenvatinib

Intervention Type

Procedure

Intervention Name(s)

TACE combined with lenvatinib and iodion-125 seeds brachytherapy

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

TACE combined with lenvatinib

Intervention Description

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.

Primary Outcome Measure Information:

Title

Overall survival (OS)

Description

The time from date of randomization to death due to any cause.

Time Frame

2 years.

Secondary Outcome Measure Information:

Title

Adverse events (AEs)

Description

Number of patients with AE, treatment-related AE (TRAE), AE of special interest (AESI), serious adverse event (SAE), assessed by NCI CTCAE v5.0.

Time Frame

2 years.

Title

Progression free survival (PFS) assessed by investigators according to Modified Response Evalutaion Criteria in Solid Tumors (mRECIST)

Description

The time from date of randomization until the first occurrence of disease progression (PD) or death due to any cause, whichever occurs first.

Time Frame

2 years.

Title

Objective response rate (ORR) assessed by investigators according to mRECIST

Description

The percentage of patients who had a best overall tumor response rating of complete response (CR) or partial response (PR).

Time Frame

2 years.

Title

Disease control rate (DCR) assessed by investigators according to mRECIST

Description

The percentage of patients who had a tumor response rating of CR, PR, or stable disease (SD).

Time Frame

2 years.

Title

Duration of portal patency

Description

The time from randomization until the date that complete portal vein occlusion was confirmed.

Time Frame

2 years.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age between18 and 75 years. HCC confirmed by histopathology and/or cytology, or diagnosed clinically. Accompanied with tumor thrombus involving unilateral portal vein branch. Child-Pugh class A or B. Eastern Cooperative Group performance status (ECOG) score of 0-2. Serum bilirubin ≤ 51.3 μmol/L, albumin ≥ 28g/L, ALT and AST ≤ 5 times of the upper normal limit, and creatinine ≤ 20g/L. Prothrombin time prolonged for less than 4s or international normalized ratio < 1.7. Neutrophilic granulocyte count ≥ 1.5×10^9/L, platelet count ≥ 50×10^9/L, and hemoglobin level ≥ 85g/L; At least one measurable intrahepatic target lesion. Life expectancy of at least 3 months. Exclusion Criteria: Diffuse HCC. Extrahepatic metastasis. Tumor thrombus involving both the left and right branch of portal vein or main portal vein. Hepatic vein and/or vena cava invasion. History of organ or cells transplantation. Previous treatment with TACE, intra-arterial infusion chemotherapy, radiotherapy or systemic therapy. History of other malignancies. Serious medical comorbidities. Female patients who are pregnancy or breastfeeding.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Mingyue Cai, Dr.

Phone

+86-20-34156205

cai020@yeah.net

First Name & Middle Initial & Last Name or Official Title & Degree

Kangshun Zhu, Dr.

Phone

+86-20-34156205

zhksh010@163.com

Facility Information:

Facility Name

the Second Affiliated Hospital of Guangzhou Medical University

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510260

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mingyue Cai, Dr.

Phone

+86-20-34156205

cai020@yeah.net

12. IPD Sharing Statement

Learn more about this trial

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

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