Lenvatinib+Sintilimab+TACE vs. Lenvatinib+TACE for Advanced HCC

May 29, 2023 updated by: Second Affiliated Hospital of Guangzhou Medical University

Lenvatinib, Sintilimab Plus TACE Versus Lenvatinib Plus TACE for Patients With Advanced Hepatocellular Carcinoma: a Prospective, Multicenter, Randomized Controlled Trial

This study is conducted to evaluate the efficacy and safety of lenvatinib, sintilimab plus TACE (Len-Sin-TACE) compared with lenvatinib plus TACE (Len-TACE) for patients with advanced hepatocellular carcinoma (HCC).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a multicenter, prospective and randomized controlled trial to evaluate the efficacy and safety of Len-Sin-TACE versus Len-TACE for patient with advanced HCC.

427 patients with advanced HCC (CNLC IIIa-IIIb/BCLC C stage) will be enrolled in this study. The patients will receive either Len-Sin or Len alone after first TACE using an 2:1 randomization scheme. In the Len-Sin arm, lenvatinib 12mg (body weight ≥60kg) or 8mg (body weight <60kg) P.O. qd and sintilimab (200mg I.V. q3w) will be started at 3-7 days after the first TACE. In the the Len arm, lenvatinib 12mg (body weight ≥60kg) or 8mg (body weight <60kg) P.O. qd will be started at 3-7 days after the first TACE.

TACE will be repeated if clinically indicated based on the evaluation of follow-up laboratory and imaging examination. Lenvatinib will last until disease progresses, intolerable toxicity, withdrawal of informed consent, loss of follow-up, death, or other circumstances that require termination of treatment, whichever occurs first. Sintilimab will last up to 24 months, or until disease progresses, intolerable toxicity, withdrawal of informed consent, loss of follow-up, death, or other circumstances that require termination of treatment, whichever occurs first. In the Len-Sin arm, patients will be allowed to have lenvatinib or sintilimab as a sigle agent and will be still considered on study when the other drug cause intolerable toxicity.

The primary end point of this study is overall survival (OS). The secondary endpoints are progression-free survival (PFS), time to progression (TTP), objective response rate (ORR), disease control rate (DCR), and adverse events (AEs).

Study Type

Interventional

Enrollment (Estimated)

427

Phase

  • Phase 3

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, MD
  • Phone Number: +86-20-34156205
  • Email: cai020@yeah.net

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510260
        • Recruiting
        • The Second Affiliated Hospital of Guangzhou Medical University
        • Contact:

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

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Advanced HCC (BCLC stage C, or CNLC IIIa and IIIb ) with diagnosis confirmed by histology/cytology or clinically
  • Patients who have Tumor recurrence after surgical resection or ablation are allowed to be included
  • At least one measurable intrahepatic target lesion
  • Child-Pugh class A/B
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Life expectancy of at least 3 months

Exclusion Criteria:

  • Obstructive portal vein tumor thrombus involving both the left and right portal vein or main portal vein without collateral vessels
  • Vascular invasion involving inferior vena cava
  • Central nervous system metastasis
  • Patients who received prior systemic therapy, immunotherapy, TACE, transcatheter arterial radioembolization (TARE), transcatheter arterial embolization (TAE), hepatic arterial infusion chemotherapy (HAIC) or radiation therapy for HCC
  • History of organ and cell transplantation
  • History of bleeding from esophageal and gastric varices
  • History of hepatic encephalopathy
  • hematologic examination: white blood cell count <3.0×10^9/L, platelets <50×10^9/L
  • Prothrombin time prolongation ≥ 4s
  • Severe organ (heart, lung, kidney) dysfunction
  • History of malignancy other than HCC
  • Active hepatitis B or C infection; hepatitis B virus (HBV) DNA > 1000 copies/ml; hepatitis C virus (HCV) RNA > 1000 copies/ml. Those who possess the indicators lower than the above criteria after nucleotide antiviral treatment can be enrolled

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Len-Sin-TACE
Lenvatinib, Sintilimab Plus TACE
Drug: Lenvatinib, sintilimab plus TACE
Lenvatinib 12mg (body weight ≥60kg) or 8mg (body weight <60kg) P.O. qd and sintilimab (200mg I.V. q3w) will be started at 3-7 days after the first TACE. TACE will be repeated if clinically indicated. Treatment of sintilimab will last up to 24 months. Patients will be allowed to have lenvatilib or sintilimab as a sigle agent and will be still considered on study when the other drug cause intolerable toxicity.
Active Comparator: Len-TACE
Lenvatinib Plus TACE
Drug: Lenvatinib plus TACE
Lenvatinib 12mg (body weight ≥60kg) or 8mg (body weight <60kg) P.O. qd will be started at 3-7 days after the first TACE. TACE will be repeated if clinically indicated. The interruption, dose reduction and discontinuation of lenvatinib depended on the presence and severity of toxicities according to the drug directions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: 4 years
The time from date of randomization to death due to any cause.
4 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression free survival (PFS)
Time Frame: 4 years
The time from date of randomization until the first occurrence of disease progression (according to mRECIST) or death due to any cause, whichever occurs first.
4 years
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
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

Collaborators and Investigators

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

Sponsor

Second Affiliated Hospital of Guangzhou Medical University

Investigators

  • Principal Investigator: Kangshun Zhu, MD, 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)

November 2, 2022

Primary Completion (Estimated)

October 31, 2026

Study Completion (Estimated)

October 31, 2026

Study Registration Dates

First Submitted

November 2, 2022

First Submitted That Met QC Criteria

November 2, 2022

First Posted (Actual)

November 8, 2022

Study Record Updates

Last Update Posted (Actual)

May 31, 2023

Last Update Submitted That Met QC Criteria

May 29, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MIIR-10

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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