Lenvatinib, Sintilimab, and DEB-TACE With/Without HAIC for HCC >7 cm With PVTT

Second Affiliated Hospital of Guangzhou Medical University

Status and phase: Enrolling; Phase 2

Conditions: Hepatocellular Carcinoma Non-resectable

Treatments: Combination Product: LEN+SIN+DEB-TACE; Combination Product: LEN+SIN+DEB-TACE+HAIC

Study type: Interventional

Funder types: Other

Identifiers

NCT06904183

MIIR-25

Details and patient eligibility

About

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

Full description

This is a multicenter, prospective and randomized study to evaluate the efficacy and safety of LEN+SIN+DEB-TACE+HAIC compared with LEN+SIN+DEB-TACE for unresectable large HCC (>7cm) with PVTT.

320 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+SIN+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+SIN+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 and sintilimab 200mg I.V. q3w 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).

Enrollment: 320 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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; prothrombin time prolongation ≤4 seconds
• life expectancy of at least 3 months

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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320 participants in 2 patient groups

LEN+SIN+DEB-TACE+HAIC

Experimental group

Description:

Patients will receive the combination treatment of LEN+SIN+DEB-TACE+HAIC.

Treatment:

Combination Product: LEN+SIN+DEB-TACE+HAIC

LEN+SIN+DEB-TACE

Active Comparator group

Description:

Patients will receive the combination treatment of LEN+SIN+DEB-TACE.

Treatment:

Combination Product: LEN+SIN+DEB-TACE