Lenvatinib Combined Anti-PD1 Antibody for the Advanced Hepatocellular Carcinoma

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04627012
• Other study ID #: GYEYJR-2
• Status: Completed
• Start date: January 1, 2018
• Est. completion date: July 1, 2023

Study information

• Verified date: March 2024
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: July 1, 2023
• Est. primary completion date: December 30, 2021
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anti-PD1 Antibody
• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma
• Liver Diseases

Intervention

Drug:
• Lenvatinib
12 mg (or 8 mg) once daily (QD) oral dosing.
• Opdivo
3mg/mg intravenously every 3 weeks
• Camrelizumab
200mg intravenously every 3 weeks
• Keytruda
200mg intravenously every 3 weeks
• Toripalimab
240mg intravenously every 3 weeks
• Sintilimab
200mg intravenously every 3 weeks
• Tislelizumab
200mg intravenously every 3 weeks

Locations

Country	Name	City	State
China	Second Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Sun Yat-sen University	Second Affiliated Hospital of Guangzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-Free-Survival(PFS)	Progression was defined as progressive disease by independent radiologic review according to mRECIST or death from any cause	24 months
Primary	Overall survival (OS)	OS is the length of time from the date of randomization until death from any cause.	24 months
Secondary	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.	6 months
Secondary	Disease control rate(DCR)	The proportion of patients who had a best response rating of complete response, partial response, or stable disease.	24 months
Secondary	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.	24 months