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

Summary

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).

Conditions

• Hepatocellular Carcinoma Non-resectable

Interventions

COMBINATION_PRODUCT

LEN+SIN+DEB-TACE+HAIC

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 and sintilimab 200mg I.V. q3w will be started with 7 days after the first DEB-TACE+HAIC.

COMBINATION_PRODUCT

LEN+SIN+DEB-TACE

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 and sintilimab 200mg I.V. q3w will be started with 7 days after the first DEB-TACE.

Sponsors & Collaborators

• Affiliated Hospital of Guangdong Medical University

  collaborator OTHER

• Zhongshan People's Hospital, Guangdong, China

  collaborator OTHER

• Huizhou Municipal Central Hospital

  collaborator OTHER

• Jieyang People's Hospital

  collaborator OTHER

• Guangzhou Development District Hospital

  collaborator UNKNOWN

• First People's Hospital of Foshan

  collaborator OTHER

• Anqing Municipal Hospital

  collaborator OTHER

• Jinan University Affiliated Shunde Hospital

  collaborator UNKNOWN

• Second Affiliated Hospital of Guangzhou Medical University

  lead OTHER

Principal Investigators

• Kangshun Zhu, Dr. · Second Affiliated Hospital of Guangzhou Medical University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-04-01

Primary Completion

2029-03-31

Completion

2030-03-31

Countries

• China

Study Locations