AzTrials
AzTrials

Hepatocellular CarcinomaNCT04627012

Lenvatinib Combined Anti-PD1 Antibody for the Advanced Hepatocellular Carcinoma

An observational study of Hepatocellular Carcinoma and Anti-PD1 Antibody, run by Sun Yat-sen University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Lenvatinib, Opdivo and Camrelizumab
How many people
600 participants
Where
1 siteChina
Study dates
1 Jan 2018to 1 Jul 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • Adult, Older adult

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.

Who may be able to join

  • HCC diagnosed by histopathological examination or Guidelines for Diagnosis and Treatment of Primary Liver Cancer or the recurrent HCC after surgery;
  • age between 18 and 75 years;
  • 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.
  • Previous use of any systemic therapy but intolerant, impotent or drug resistant.
  • Child-Pugh class A or B;
  • Eastern Cooperative Group performance status (ECOG) score of 0-2;
Show all 9Show fewer
  • 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
  • Prothrombin time ≤18s or international normalized ratio < 1.7.
  • Ability to understand the protocol and to agree to and sign a written informed consent document.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

China1 site

  • Second Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, 510000

Other trials in China

About this study

Official title: 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.

Read the 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.

Being tested
Lenvatinib, Opdivo, Camrelizumab, Keytruda, Toripalimab
Keywords
Tislelizumab, Lenvatinib, Toripalimab, Sintilimab, Camrelizumab, Keytruda, Opdivo
Medical subject headings
Carcinoma, Hepatocellular, Liver Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LenvatinibDrug

    12 mg (or 8 mg) once daily (QD) oral dosing.

  • OpdivoDrug

    3mg/mg intravenously every 3 weeks

  • CamrelizumabDrug

    200mg intravenously every 3 weeks

  • KeytrudaDrug

    200mg intravenously every 3 weeks

  • ToripalimabDrug

    240mg intravenously every 3 weeks

  • SintilimabDrug

    200mg intravenously every 3 weeks

  • TislelizumabDrug

    200mg intravenously every 3 weeks

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-Free-Survival(PFS)

    Progression was defined as progressive disease by independent radiologic review according to mRECIST or death from any cause

    Measured: 24 months

  2. Overall survival (OS)

    OS is the length of time from the date of randomization until death from any cause.

    Measured: 24 months

Secondary outcomes (3)

  1. Objective response rate (ORR)

    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.

    Measured: 6 months

  2. Disease control rate(DCR)

    The proportion of patients who had a best response rating of complete response， partial response, or stable disease.

    Measured: 24 months

  3. Adverse events

    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.

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Nov 2020
  2. Study start1 Jan 2018
  3. Primary completion30 Dec 2021
  4. Study completion1 Jul 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
600 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04627012
Sponsor's protocol ID
GYEYJR-2
Status last verified
Mar 2024
First submitted
8 Nov 2020
Last updated
6 Mar 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Hepatocellular Carcinoma and Anti-PD1 Antibody, run by Sun Yat-sen University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free-Survival(PFS) (time frame: 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04627012.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in