Lenvatinib Combined Anti-PD1 Antibody for the Advanced Hepatocellular Carcinoma

March 5, 2024 updated by: Zhou Qunfang, Sun Yat-sen University

The Effectiveness and Safety of Lenvatinib Combined Anti-programmed Death Immunotherapy for the Advanced Hepatocellular Carcinoma

For the advanced hepatocellular carcinoma (HCC), the targeted therapy and immunotherapy are recommended. This study focused on the management of Lenvatinib combined anti-PD1 antibody for the HCC. This study will create a database that will provide clinical parameters and outcomes of patients undergoing Lenvatinib and anti-PD1 antibody as part of their standard of care in hopes of answering key clinical questions.

Study Overview

Detailed Description

Lenvatinib was non-inferior to sorafenib in overall survival in untreated advanced hepatocellular carcinoma. The programmed cell death protein-1 (PD-1) antibody, was effective and tolerable in patients with hepatocellular carcinoma and portal vein tumor thrombus. We aimed to describe the efficacy and safety of Lenvatinib combined anti-PD1 antibody in patients with hepatocellular carcinoma who can not receive redical therapy.

Study Type

Observational

Enrollment (Actual)

600

Contacts and Locations

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

Study Locations

    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Second Affiliated Hospital of Guangzhou Medical University

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

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

For the advanced hepatocellular carcinoma (HCC), the targeted therapy and immunotherapy are recommended. This study focused on the management of Lenvatinib combined anti-PD1 antibody for the HCC. This study will create a database that will provide clinical parameters and outcomes of patients undergoing Lenvatinib and anti-PD1 antibody as part of their standard of care in hopes of answering key clinical questions.

Description

Inclusion Criteria:

  1. HCC diagnosed by histopathological examination or Guidelines for Diagnosis and Treatment of Primary Liver Cancer or the recurrent HCC after surgery;
  2. age between 18 and 75 years;
  3. Stage B (middle stage) or C (late stage) HCC determined in accordance with Barcelona Clinic Liver Cancer staging system (BCLC stage). In case of stage B.
  4. Previous use of any systemic therapy but intolerant, impotent or drug resistant.
  5. Child-Pugh class A or B;
  6. Eastern Cooperative Group performance status (ECOG) score of 0-2;
  7. Hemoglobin ≥ 8.5 g/dL Total bilirubin ≤ 30mmol/L Serum albumin ≥ 32 g/L ASL and AST ≤ 5 x upper limit of normal Serum creatinine ≤ 1.5 x upper limit of normal INR ≤ 1.5 or PT/APTT within normal limits Absolute neutrophil count (ANC) >1,500/mm3
  8. Prothrombin time ≤18s or international normalized ratio < 1.7.
  9. Ability to understand the protocol and to agree to and sign a written informed consent document.

Exclusion Criteria:

  1. Cholangiocellular carcinoma (ICC);
  2. Patients with cancer thrombus in the main trunk of portal vein (Vp4), or cancer thrombus in inferior vena cava should be excluded;
  3. The survival or patients less than 3 months.
  4. Serious medical comorbidities.
  5. Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy
  6. Known history of HIV
  7. History of organ allograft
  8. Known or suspected allergy to the investigational agents or any agent given in association with this trial.
  9. Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
  10. Evidence of bleeding diathesis.
  11. Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.

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

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-Free-Survival(PFS)
Time Frame: 24 months
Progression was defined as progressive disease by independent radiologic review according to mRECIST or death from any cause
24 months
Overall survival (OS)
Time Frame: 24 months
OS is the length of time from the date of randomization until death from any cause.
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate (ORR)
Time Frame: 6 months
ORR, as determined based on tumor response according to RECIST 1.1, is defined as the proportion of all randomized subjects whose best overall response (BOR) is either a CR or PR.
6 months
Disease control rate(DCR)
Time Frame: 24 months
The proportion of patients who had a best response rating of complete response, partial response, or stable disease.
24 months
Adverse events
Time Frame: 24 months
Safety will be evaluated according to the NCI CTCAE Version 4.03. All observations pertinent to the safety of the study medication will be recorded on the CRF and included in the final report.
24 months

Collaborators and Investigators

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

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)

January 1, 2018

Primary Completion (Actual)

December 30, 2021

Study Completion (Actual)

July 1, 2023

Study Registration Dates

First Submitted

November 8, 2020

First Submitted That Met QC Criteria

November 8, 2020

First Posted (Actual)

November 13, 2020

Study Record Updates

Last Update Posted (Estimated)

March 6, 2024

Last Update Submitted That Met QC Criteria

March 5, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

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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