HAIC Plus Lenvatinib and PD-1 Antibody Versus HAIC Plus Lenvatinib for Advanced HCC

NCT ID: NCT03803254

Last Updated: 2019-05-06

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-03
• Study Completion Date: 2021-01-01

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of hepatic arterial infusion chemotherapy of oxaliplatin, 5-fluorouracil and leucovorin plus lenvatinib and programmed cell death protein-1 antibody compared with lenvtinib Alone in patients with hepatic arterial infusion chemotherapy of oxaliplatin, 5-fluorouracil and leucovorin plus lenvatinib for advanced hepatocellular carcinoma (HCC)

Detailed Description

Hepatic arterial infusion chemotherapy (HAIC) of oxaliplatin, 5-fluorouracil and leucovorin was effective and safe for hepatocellular carcinoma. Lenvatinib was non-inferior to sorafenib in overall survival in untreated 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 compared HAIC plus lenvatinib and PD-1 antibody with HAIC plus lenvatinib. Thus, the investigators carried out this prospective randomized control study to find out it.

Conditions

Hepatocellular Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

HAIC plus lenvatinib and PD-1 antibody

Hepatic arterial infusion chemotherapy plus lenvatinib and programmed cell death protein-1 antibody

Group Type: EXPERIMENTAL

Hepatic arterial infusion chemotherapy

Intervention Type: PROCEDURE

administration of oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries

Folfox Protocol

Intervention Type: DRUG

Oxaliplatin , fluorouracil, and leucovorin

Lenvatinib

Intervention Type: DRUG

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

PD-1 antibody

Intervention Type: DRUG

3mg/kg intravenously every 2 weeks

HAIC plus lenvatinib

Hepatic arterial infusion chemotherapy plus lenvatinib

Group Type: ACTIVE_COMPARATOR

Hepatic arterial infusion chemotherapy

Intervention Type: PROCEDURE

administration of oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries

Folfox Protocol

Intervention Type: DRUG

Oxaliplatin , fluorouracil, and leucovorin

Lenvatinib

Intervention Type: DRUG

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

Interventions

Hepatic arterial infusion chemotherapy

administration of oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries

Intervention Type: PROCEDURE

Folfox Protocol

Oxaliplatin , fluorouracil, and leucovorin

Intervention Type: DRUG

Lenvatinib

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

Intervention Type: DRUG

PD-1 antibody

3mg/kg intravenously every 2 weeks

Intervention Type: DRUG

Eligibility Criteria

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 C
• Eastern Cooperative Oncology Group performance status of 0 to 2
• with no previous treatment
• No Cirrhosis or cirrhotic status of Child-Pugh class A only
• Not amendable to surgical resection ,local ablative therapy and any other cured treatment.
• The following laboratory parameters:

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kaiping Central Hospital

OTHER

Sponsor Role: collaborator

Guangzhou No.12 People's Hospital

OTHER_GOV

Sponsor Role: collaborator

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Shi Ming

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ming Shi, MD

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

Locations

Cancer Center Sun Yat-sen University

Guangzhou, Guangdong, China

Guangzhou Twelfth People 's Hospita

Guangzhou, Guangdong, China

Kaiping Central Hospital

Kaiping, Guangdong, China

Countries

China

Other Identifiers

HCC-S058

Identifier Type: -

Identifier Source: org_study_id