Lenvatinib Combined Anti-PD1 Antibody for the Advanced Hepatocellular Carcinoma

Sponsor

Sun Yat-sen University (Other)

Overall Status

Completed

CT.gov ID

NCT04627012

Collaborator

Second Affiliated Hospital of Guangzhou Medical University (Other)

600

Enrollment

Location

53.9

Actual Duration (Months)

11.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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. 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.

Condition or Disease	Intervention/Treatment	Phase
Hepatocellular Carcinoma Anti-PD1 Antibody Liver Diseases	Drug: Lenvatinib Drug: Opdivo Drug: Camrelizumab Drug: Keytruda Drug: Toripalimab Drug: Sintilimab Drug: Tislelizumab

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 Design

Study Type:

Observational

Actual Enrollment :

600 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

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

Actual Study Start Date :

Jan 1, 2018

Actual Primary Completion Date :

Dec 30, 2021

Actual Study Completion Date :

Jul 1, 2022

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Objective response rate (ORR) [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.
Disease control rate(DCR) [24 months]
The proportion of patients who had a best response rating of complete response， partial response, or stable disease.
Adverse events [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

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.