Lenvatinib, Sintilimab Plus SIRT for Unresectable HCC

September 12, 2023 updated by: Second Affiliated Hospital of Guangzhou Medical University

Lenvatinib, Sintilimab Plus Y-90 Selective Internal Radiation Therapy for Patients With Unresectable Intermediate-advanced Hepatocellular Carcinoma: a Prospective, Single-center, Single Arm Trial

This study is conducted to evaluate the efficacy and safety of lenvatinib, sintilimab plus Y-90 selective internal radiation therapy (SIRT) for patients with unresectable intermediate-advanced hepatocellular carcinoma (HCC).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a single-center, prospective study to evaluate the efficacy and safety of lenvatinib, sintilimab plus SIRT (Len-Sin-SIRT) in patient with unresectable HCC.

30 patients with unresectable intermediate-advanced HCC (BCLC B/C stage) will be enrolled in this study. The patients will receive lenvatinib (body weight ≥60kg, 12mg; body weight <60kg, 8mg; P.O. QD) and sintilimab (200mg I.V. Q3W) at 3-7 days after SIRT. 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. 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.

The primary end point of this study is Progression free survival (PFS) per mRECIST. The secondary endpoints are PFS per RECIST 1.1, objective response rate (ORR), disease control rate (DCR), overall survival (OS) and adverse events (AEs).

Study Type

Interventional

Enrollment (Estimated)

30

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:
        • Principal Investigator:
          • Kangshun Zhu, Dr.
        • Sub-Investigator:
          • Mingyue Cai, 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:

  • Unresectable HCC (BCLC stage B/C) with diagnosis confirmed by histology/cytology or clinically
  • At least one measurable untreated lesion
  • Intrahepatic tumors can be treated with 1-2 session of SIRT
  • Child-Pugh score 5-7
  • Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1
  • Life expectancy of at least 3 months
  • Patients with active hepatitis B are allowed, but they need to receive antiviral treatment to achieve a HBV DNA<10^3 IU/mL
  • Patients with hepatitis C need to finish the anti-HCV treatment

Exclusion Criteria:

  • tumor extent ≥70% liver occupation
  • Tumor thrombus involving main portal vein or both the first left and right branch of portal vein
  • Vena cava invasion
  • Central nervous system metastasis
  • Metastatic disease that involves major airways or blood vessels
  • Patients who previously received hepatic arterial infusion chemotherapy (HAIC), transarterial chemoembolization (TACE), transarterial embolization (TAE), radiotherapy, systemic therapy, or immunotherapy for HCC
  • History of organ and cell transplantation
  • Prior esophageal and/or gastric varices bleeding
  • History of hepatic encephalopathy
  • Peripheral blood white blood cell count<3×10^9/L, platelet count<50×10^9/L
  • Prolongation of prothrombin time ≥ 4 seconds
  • Severe organ dysfunction (heart, lungs, kidneys)
  • History of malignancy other than HCC
  • HBsAg and anti-HCV antibody positive concurrently
  • Human immunodeficiency virus (HIV) infected

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Len-Sin-SIRT
Lenvatinib, sintilimab plus SIRT
Drug: Lenvatinib, sintilimab plus SIRT
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 SIRT. 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression free survival (PFS) according to mRECIST
Time Frame: 2.5 years
The time from initiation of treatment until the first occurrence of disease progression or death from any cause, whichever occurs first.
2.5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression free survival (PFS) according to RECIST 1.1
Time Frame: 2.5 years
The time from initiation of treatment until the first occurrence of disease progression or death from any cause, whichever occurs first.
2.5 years
Objective response rate (ORR)
Time Frame: 2.5 years
The percentage of patients who had a best overall tumor response rating of complete response (CR) or partial response (PR) according to mRECIST and RECIST 1.1
2.5 years
Disease control rate (DCR)
Time Frame: 2.5 years
The percentage of patients who had a tumor response rating of CR, PR, or stable disease (SD) according to mRECIST and RECIST 1.1
2.5 years
Overall survival (OS)
Time Frame: 2.5 years
The time from initiation of treatment until the date of death from any cause.
2.5 years
Adverse Events (AEs)
Time Frame: 2.5 years
Number of patients with AEs assessed by NCI CTCAE v5.0.
2.5 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

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)

August 10, 2023

Primary Completion (Estimated)

January 9, 2026

Study Completion (Estimated)

August 9, 2026

Study Registration Dates

First Submitted

August 7, 2023

First Submitted That Met QC Criteria

August 8, 2023

First Posted (Actual)

August 15, 2023

Study Record Updates

Last Update Posted (Actual)

September 14, 2023

Last Update Submitted That Met QC Criteria

September 12, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MIIR-14

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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