Lenvatinib Plus PD-1 Antibody vs TACE for Intermediate-stage HCC Beyond Up-to-seven Criteria

Hepatocellular Carcinoma Clinical Trial

Official title:

Lenvatinib Plus Programmed Cell Death Protein-1 (PD-1) Antibody Versus Transarterial Chemoembolization for Intermediate-stage Hepatocellular Carcinoma Beyond Up-to-seven Criteria

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03791918
• Other study ID #: HCC-S065
• Status: Withdrawn
• Phase: Phase 3
• Start date: January 1, 2019
• Est. completion date: January 1, 2022

Study information

• Verified date: January 2019
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and safety of lenvatinib combined with PD-1 antibody compared with transarterial chemoembolization (TACE) for patients with intermediate-stage hepatocellular carcinoma (HCC) beyond up-to-seven criteria

Description:

Transarterial chemoembolization (TACE) is the most widely used palliative treatment for hepatocellular carcinoma (HCC) patients. While a number of studies demonstrate poor effect of TACE for patients with hepatocellular carcinoma staged BCLC A/B especially for those with tumor beyond up-to-seven criteria. Recently, Lenvatinib was proved non-inferior to sorafenib in overall survival in advanced hepatocellular carcinoma, and Programmed Cell Death Protein-1 (PD-1) antibody was effective and tolerable in patients with advanced hepatocellular carcinoma. No study has evaluated the efficacy and safety of lenvatinib plus PD-1 antibody in intermediate-stage HCC. Thus, the investigators carried out this prospective randomized control to demonstrate the superiority of lenvatinib combined with PD-1 antibody over TACE.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 1, 2022
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• The diagnosis of HCC was based on the diagnostic criteria for HCC used by the European Association for the Study of the Liver (EASL)

• Patients must have at least one tumor lesion that can be accurately measured according to EASL criteria.

• Barcelona clinic liver cancer-stage B

• Beyond up-to-seven criteria (hepatocellular carcinomas with seven as the sum of the size of the largest tumor [in cm] and the number of tumors)

• Eastern Cooperative Oncology Group performance status of 0 to 1

• No Cirrhosis or cirrhotic status of Child-Pugh class A only

• Not applicable for transarterial chemoembolization, surgical resection, and local ablative therapy.

• The following laboratory parameters:

Platelet count = 75,000/µL Hemoglobin = 8.5 g/dL Total bilirubin = 30mmol/ L Serum albumin = 30 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

• Ability to understand the protocol and to agree to and sign a written informed consent document

Exclusion Criteria:

• 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.

• Known central nervous system tumors including metastatic brain disease

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Drug:
• Lenvatinib
12 mg (or 8 mg) once daily (QD) oral dosing.
• PD-1 antibody
3mg/kg intravenously every 2 weeks

Procedure:
• TACE
A standard hepatic artery catheter was introduced via the femoral artery percutaneously. Selective catheterization of the proper hepatic artery was performed using standard diagnostic catheters and fluoroscopic guidance. TACE Drug Protocol were injected.

Drug:
• TACE Drug Protocol
lipiodol mixed with chemotherapy drugs(EADM , lobaplatin, and MMC) followed by polyvinyl alcohol particles (PVA)

Locations

Country	Name	City	State
China	Cancer Center Sun Yat-sen University	Guangzhou	Guangdong
China	Guangzhou Twelfth People 's Hospita	Guangzhou	Guangdong
China	Kaiping Central Hospital	Kaiping	Guangdong

Sponsors (3)

Lead Sponsor	Collaborator
Sun Yat-sen University	Guangzhou No.12 People's Hospital, Kaiping Central Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival		24 months
Secondary	Time to progression		24 months
Secondary	Adverse Events		24 months
Secondary	Progression free survival		24 months