Clinical trial NCT04967495: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Hepatocellular Carcinoma Non-resectable
Keywords: Hepatocellular Carcinoma
Transarterial chemoembolization
Tyrosine kinase inhibitor
iodion-125 seed
Lead sponsor: Second Affiliated Hospital of Guangzhou Medical University
Sponsor class: OTHER
First posted: 2021-07-19
Enrollment: 171
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Overall survival (OS)
timeFrame: 2 years.
Secondary outcomes:
measure: Adverse events (AEs)
timeFrame: 2 years.
measure: Progression free survival (PFS) assessed by investigators according to Modified Response Evalutaion Criteria in Solid Tumors (mRECIST)
timeFrame: 2 years.
measure: Objective response rate (ORR) assessed by investigators according to mRECIST
timeFrame: 2 years.
measure: Disease control rate (DCR) assessed by investigators according to mRECIST
timeFrame: 2 years.
measure: Duration of portal patency
timeFrame: 2 years.
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: the Second Affiliated Hospital of Guangzhou Medical University
state: Guangdong
Study officials:
References: