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

April 28, 2025 updated by: Second Affiliated Hospital of Guangzhou Medical University

Lenvatinib, Sintilimab, and Drug-Eluting Beads Transarterial Chemoembolization With or Without Hepatic Arterial Infusion Chemotherapy for Hepatocellular Carcinoma >7 cm With Portal Vein Tumor Thrombus: A Multicenter, Randomized Controlled Trial

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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).

Study Type

Interventional

Enrollment (Estimated)

320

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Mingyue Cai, Dr.
  • Phone Number: +86-20-34156205
  • Email: cai020@yeah.net

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510260
        • Recruiting
        • The second Affiliated Hospital of Guangzhou Medical University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Kangshun Zhu, Dr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LEN+SIN+DEB-TACE+HAIC
Patients will receive the combination treatment of LEN+SIN+DEB-TACE+HAIC.
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.
Active Comparator: LEN+SIN+DEB-TACE
Patients will receive the combination treatment of LEN+SIN+DEB-TACE.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to progression (TTP)
Time Frame: 4 years
The time from date of randomization until the first occurrence of disease progression (according to mRECIST).
4 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate (ORR)
Time Frame: 4 years
The proportion of patients with the best response of complete response (CR) or partial response (PR) according to mRECIST.
4 years
Disease control rate (DCR)
Time Frame: 4 years
The proportion of patients with the best response of CR, PR, or stable disease (SD) according to mRECIST.
4 years
Adverse Events (AEs)
Time Frame: 4 years.
Number of patients with AEs assessed by Common Terminology Criteria for Adverse Events v5.0.
4 years.
Overall survival (OS)
Time Frame: 5 years
The time from date of randomization to death due to any cause.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital of Guangzhou Medical University

Collaborators

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

Investigators

  • Study Chair: Kangshun Zhu, Dr., Second Affiliated Hospital of Guangzhou Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2025

Primary Completion (Estimated)

March 31, 2029

Study Completion (Estimated)

March 31, 2030

Study Registration Dates

First Submitted

March 25, 2025

First Submitted That Met QC Criteria

March 25, 2025

First Posted (Actual)

April 1, 2025

Study Record Updates

Last Update Posted (Actual)

April 29, 2025

Last Update Submitted That Met QC Criteria

April 28, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MIIR-25

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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