Lenvatinib Plus DEB-TACE and HAIC vs. Lenvatinib Plus DEB-TACE for Large HCC With PVTT

Trial Title: Lenvatinib Plus DEB-TACE and HAIC vs. Lenvatinib Plus DEB-TACE for Large HCC With PVTT

NCT ID: NCT06492395

Condition: Hepatocellular Carcinoma Non-resectable

Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Chlorotrianisene

Conditions: Keywords:
hepatocellular carcinoma
lenvatinib
transarterial chemoembolization
drug-eluting bead
hepatic arterial infusion chemotherapy
portal vein tumor thrombosis

Study type: Interventional

Study phase: Phase 3

Overall status: Not yet recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Combination Product
Intervention name: Len+DEB-TACE+HAIC
Description: For DEB-TACE, superselective catheterization is performed and DEBs loaded with pirarubicin is use for chemoembolization. The embolization end point was blood stasis of the tumor-feeding arteries. In order to reduce the risk of complications, the embolization end point was not achieved in the initial TACE but in the second or third TACE session. After each chemoembolization, the microcatheter is reserved at the main hepatic tumor-feeding artery. The FOLFOX-based regimen is intra-arterially administered. During follow-up, the treatment of DEB-TACE and/or HAIC will be repeated for viable tumors based on the evaluation of the follow-up laboratory and imaging examination. Lenvatinib 12mg (body weight ≥60kg) or 8mg (body weight <60kg) P.O. qd will be started with 7 days after the first DEB-TACE+HAIC.
Arm group label: Len+DEB-TACE+HAIC

Intervention type: Combination Product
Intervention name: Len+DEB-TACE
Description: For DEB-TACE, superselective catheterization is performed and DEBs loaded with pirarubicin is use for chemoembolization. The embolization end point was blood stasis of the tumor-feeding arteries. In order to reduce the risk of complications, the embolization end point was not achieved in the initial TACE but in the second or third TACE session. During follow-up, the treatment of DEB-TACE will be repeated for viable tumors based on the evaluation of the follow-up laboratory and imaging examination. Lenvatinib 12mg (body weight ≥60kg) or 8mg (body weight <60kg) P.O. qd will be started with 7 days after the first DEB-TACE+HAIC.
Arm group label: Len+DEB-TACE

Summary: This study is conducted to evaluate the efficacy and safety of lenvatinib plus transarterial chemoembolization (TACE) with drug-eluting beads (DEB-TACE) and hepatic artery infusion chemotherapy (HAIC) with FOLFOX regemen (Len+DEB-TACE+HAIC) versus lenvatinib plus DEB-TACE (Len+DEB-TACE) for large hepatocellular carcinoma (> 7cm) with portal vein tumor thrombosis (PVTT).

Detailed description: This is a multicenter, prospective and randomized study to evaluate the efficacy and safety of Len+DEB-TACE+HAIC compared with Len+DEB-TACE for unresectable large HCC (>7cm) with PVTT. 178 patients with large HCC (> 7cm) and PVTT will be enrolled in this study. The patients will receive either Len+DEB-TACE+HAIC or Len+DEB-TACE using an 1:1 randomization scheme. In the Len+DEB-TACE+HAIC arm, the microcatheter will be reserved at the main hepatic tumor-feeding artery after DEB-TACE and chemotherapy drugs (oxaliplatin, fluorouracil and leucovorin; FOLFOX-based regimen) will be intra-arterially administered though the microcatheter. DEB-TACE+HAIC treatments can be repeated based on the evaluation of follow-up laboratory and imaging examination by the multidisciplinary team. In the Len+DEB-TACE arm, patients will be treated with DEB-TACE alone. TACE treatment can be repeated based on the evaluation of follow-up laboratory and imaging examination by the multidisciplinary team. In both arms, lenvatinib 12mg (body weight ≥60kg) or 8mg (body weight <60kg) P.O. qd will be started within 7 days after the first DEB-TACE+HAIC/DEB-TACE. The primary end point of this study is time to progression (TTP). The secondary endpoints are tumor response (objective response rate and disease control rate), overall survival (OS), and adverse events (AEs).

Criteria for eligibility:
Criteria:
Inclusion Criteria: - a confirmed diagnosis of HCC - the largest intrahepatic lesion >7 cm - presence of PVTT on imaging - tumor recurrence after curative treatment (hepatectomy or ablation) is eligible for enrollment - Eastern Cooperative Oncology Group performance status ≤1 - Child-Pugh class A/B - adequate hematologic and organ function, with leukocyte count>3.0×10^9/L, neutrophil count>1.5×10^9/L, platelet count≥75×10^9/L, hemoglobin 85 g/L, alanine transaminase and aspartate transaminase≤5×upper limit of the normal, creatinine clearance rate≤1.5×upper limit of the normal - life expectancy of at least 3 months Exclusion Criteria: - Diffuse HCC - accompanied with vena cava tumor thrombus - central nervous system involvement - previous treatment with TACE, HAIC, TAE, radiotherapy, or systemic therapy - organ (heart and kidneys) dysfunction, unable to tolerate TACE or HAIC treatment - history of other malignancies - uncontrollable infection - history of HIV - history of organ or cells transplantation - prothrombin time prolongation >4 s

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Locations:

Facility:
Name: The Second Affiliated Hospital of Guangzhou Medical University

Address:
City: Guangzhou
Zip: 510260
Country: China

Start date: August 1, 2024

Completion date: July 31, 2027

Lead sponsor:
Agency: Second Affiliated Hospital of Guangzhou Medical University
Agency class: Other

Source: Second Affiliated Hospital of Guangzhou Medical University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06492395