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

Not Applicable

Recruiting

• Conditions: Hepatocellular Carcinoma Non-resectable
• Interventions: Procedure: TACE combined with lenvatinib and iodion-125 seeds brachytherapy; Procedure: TACE combined with lenvatinib

• Registration Number: NCT04967495
• Lead Sponsor: Second Affiliated Hospital of Guangzhou Medical University

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.

Study Timeline

• Study First Submitted: 2021-07-08
• Study First Submitted QC: 2021-07-08
• Study Start: 2021-07-09
• Study First Posted: 2021-07-19
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-16
• Last Update Posted: 2023-05-18
• Primary Completion: 2025-01-08
• Study Completion: 2025-01-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 171

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TACE-Len-I	TACE combined with lenvatinib and iodion-125 seeds brachytherapy	TACE combined with lenvatinib and iodion-125 seeds brachytherapy
TACE-Len	TACE combined with lenvatinib	TACE combined with lenvatinib

Primary Outcome Measures

Name	Time	Method
Overall survival (OS)	2 years.	The time from date of randomization to death due to any cause.

Secondary Outcome Measures

Name	Time	Method
Duration of portal patency	2 years.	The time from randomization until the date that complete portal vein occlusion was confirmed.
Adverse events (AEs)	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.
Objective response rate (ORR) assessed by investigators according to mRECIST	2 years.	The percentage of patients who had a best overall tumor response rating of complete response (CR) or partial response (PR).
Progression free survival (PFS) assessed by investigators according to Modified Response Evalutaion Criteria in Solid Tumors (mRECIST)	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.
Disease control rate (DCR) assessed by investigators according to mRECIST	2 years.	The percentage of patients who had a tumor response rating of CR, PR, or stable disease (SD).

Trial Locations

Locations (1)

the Second Affiliated Hospital of Guangzhou Medical University; 🇨🇳 Guangzhou, Guangdong, China