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

NCT06904183 | Recruiting Phase 2

• 1 other identifier: MIIR-25
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

hepatocellular carcinoma; lenvatinib; transarterial chemoembolization; drug-eluting bead; hepatic arterial infusion chemotherapy; portal vein tumor thrombosis; sintilimab

Outcome Measures

Primary Outcomes (1)

• Time to progression (TTP)

  The time from date of randomization until the first occurrence of disease progression (according to mRECIST).

  4 years

Secondary Outcomes (4)

• Objective response rate (ORR)

  4 years

• Disease control rate (DCR)

  4 years

• Overall survival (OS)

  5 years

• Adverse Events (AEs)

  4 years.

Study Arms (2)

LEN+SIN+DEB-TACE+HAIC

EXPERIMENTAL

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

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

LEN+SIN+DEB-TACE

ACTIVE COMPARATOR

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

Combination Product: LEN+SIN+DEB-TACE

Interventions

LEN+SIN+DEB-TACE+HAIC COMBINATION_PRODUCT

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.

LEN+SIN+DEB-TACE+HAIC

LEN+SIN+DEB-TACE COMBINATION_PRODUCT

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.

LEN+SIN+DEB-TACE

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Second Affiliated Hospital of Guangzhou Medical University: lead
• Affiliated Hospital of Guangdong Medical University: collaborator
• Zhongshan People's Hospital, Guangdong, China: collaborator
• Huizhou Municipal Central Hospital: collaborator
• Jieyang People's Hospital: collaborator
• Guangzhou Development District Hospital: collaborator
• First People's Hospital of Foshan: collaborator
• Anqing Municipal Hospital: collaborator
• Jinan University Affiliated Shunde Hospital: collaborator

Study Sites (1)

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510260, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Kangshun Zhu, Dr.

  Second Affiliated Hospital of Guangzhou Medical University

  STUDY CHAIR

Central Study Contacts

Mingyue Cai, Dr.

CONTACT

+86-20-34156205; cai020@yeah.net

Kangshun Zhu, Dr.

CONTACT

+86-20-34156205; zhksh010@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2025
• First Posted: April 1, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): March 31, 2029
• Study Completion (Estimated): March 31, 2030
• Last Updated: April 29, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)