- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04627012
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
Status
Completed
Intervention / Treatment
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:
- 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;
- 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.
Exclusion Criteria:
- 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
- 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.
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.
Sponsor
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
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Adenocarcinoma
- Neoplasms, Glandular and Epithelial
- Digestive System Neoplasms
- Liver Neoplasms
- Liver Diseases
- Carcinoma
- Carcinoma, Hepatocellular
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Antineoplastic Agents, Immunological
- Protein Kinase Inhibitors
- Immune Checkpoint Inhibitors
- Pembrolizumab
- Lenvatinib
- Tislelizumab
Other Study ID Numbers
- GYEYJR-2
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.
Clinical Trials on Liver Diseases
-
King's College Hospital NHS TrustSamsung MedisonRecruitingHepatitis | Liver Fat | NAFLD | Fibrosis, Liver | Liver Disease Chronic | Liver Steatoses | NASH With FibrosisUnited Kingdom
-
Beijing Chao Yang HospitalUnknownLiver Transplantation | End Stage Liver DIseaseChina
-
Beijing Friendship HospitalUnknownNonalcoholic Fatty Liver Disease | Liver Steatosis | Liver FibrosisChina
-
Shiraz University of Medical SciencesCompletedFatty Liver | Fatty Liver, NonalcoholicIran, Islamic Republic of
-
Institute of Liver and Biliary Sciences, IndiaCompletedAcute Liver FailureIndia
-
Medical College of WisconsinRecruiting
-
Beijing Continent Pharmaceutical Co, Ltd.RecruitingAcute-On-Chronic Liver Failure | Acute Liver FailureChina
-
HaEmek Medical Center, IsraelTerminatedPatients With Fatty Liver DiseaseIsrael
-
Taipei City HospitalThe One Biopharmaceutical Co., Ltd.CompletedNon-alcoholic Fatty Liver Disease | Liver Fibrosis | Liver InjuryTaiwan
-
Chuncheon Sacred Heart HospitalSuspendedChronic Liver Disease | Acute Derangement of Liver FunctionKorea, Republic of
Clinical Trials on Lenvatinib
-
Memorial Sloan Kettering Cancer CenterCompletedHead and Neck Cancer | Head and Neck Squamous Cell Carcinoma | Head and Neck Carcinoma | Cutaneous Squamous Cell CarcinomaUnited States
-
Fudan UniversityActive, not recruitingHepatocellular CarcinomaChina
-
Shanghai Junshi Bioscience Co., Ltd.Active, not recruitingAdvanced Hepatocellular Carcinoma (HCC)Italy, Poland, Singapore, United States, China, Ukraine
-
Regina Elena Cancer InstituteUniversity of Pisa; University of Roma La Sapienza; University of Turin, Italy; Istituto Oncologico Veneto IRCCS and other collaboratorsRecruitingDifferentiated Thyroid Cancer | GenderItaly
-
Shandong New Time Pharmaceutical Co., LTDRecruitingHepatocellular CarcinomaChina
-
Cancer Institute and Hospital, Chinese Academy...Active, not recruitingHepatocellular Carcinoma | Radiotherapy | LenvatinibChina
-
CStone PharmaceuticalsActive, not recruitingHepatocellular CarcinomaSpain, China, United States, Poland, Italy, Taiwan
-
Eisai Inc.Merck Sharp & Dohme LLCCompletedSolid TumorsUnited States, China, Belgium, Australia, Italy, Korea, Republic of, Germany, Netherlands, Poland, Romania, Thailand
-
Eisai Inc.CompletedThyroid CancerUnited States, Australia, France, Poland, United Kingdom, Italy
-
Shanghai Zhongshan HospitalActive, not recruitingCholangiocarcinoma, IntrahepaticChina