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

Hepatocellular Carcinoma Non-resectable Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04967495
• Other study ID #: MIIR-07
• Status: Recruiting
• Phase: N/A
• Start date: July 9, 2021
• Est. completion date: January 8, 2025

Study information

• Verified date: May 2023
• Source: Second Affiliated Hospital of Guangzhou Medical University
• Contact: Mingyue Cai, Dr.
• Phone: +86-20-34156205
• Email: cai020[@]yeah.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 171
• Est. completion date: January 8, 2025
• Est. primary completion date: January 8, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma Non-resectable

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	the Second Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital of Guangzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival (OS)	The time from date of randomization to death due to any cause.	2 years.
Secondary	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.	2 years.
Secondary	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.	2 years.
Secondary	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).	2 years.
Secondary	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).	2 years.
Secondary	Duration of portal patency	The time from randomization until the date that complete portal vein occlusion was confirmed.	2 years.