TACE Plus PD-1 Antibody vs TACE Alone for Unresectable HCC

NCT ID: NCT03782831

Last Updated: 2019-05-02

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-11
• Study Completion Date: 2020-06-01

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of transarterial chemoembolization (TACE) combined with programmed cell death protein-1 (PD-1) antibody compared with TACE Alone in patients with unresectable hepatocellular carcinoma (HCC)

Detailed Description

Transarterial chemoembolization (TACE) is the first-line treatment for patients with unrestable hepatocellular carcinoma (HCC) at intermediate-stage. Programmed cell death protein-1 (PD-1) antibody is effective and safe for advanced HCC. No study has compared the efficacy and safety of TACE plus PD-1 antibody and TACE alone. 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

TACE plus PD-1 antibody

Patients received hepatic intra-arterial infusion with lipiodol mixed with chemotherapy drugs (EADM, lobaplatin, and MMC), and embolization with polyvinyl alcohol particles (PVA) on demand. In addition, patients received 3mg/kg PD-1 antibody intravenously every 2 weeks up to documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.

Group Type: EXPERIMENTAL

TACE

Intervention Type: PROCEDURE

Hepatic intra-arterial infusion with lipiodol mixed with chemotherapy drugs (EADM, lobaplatin, and MMC), and embolization with polyvinyl alcohol particles (PVA).

PD-1 antibody

Intervention Type: DRUG

3mg/kg intravenously every 2 weeks

TACE alone

Patients received hepatic intra-arterial infusion with lipiodol mixed with hemotherapy drugs (EADM, lobaplatin, and MMC), and embolization with polyvinyl alcohol particles (PVA) on demand. In addition, patients received placebos intravenously every 2 weeks

Group Type: ACTIVE_COMPARATOR

TACE

Intervention Type: PROCEDURE

Hepatic intra-arterial infusion with lipiodol mixed with chemotherapy drugs (EADM, lobaplatin, and MMC), and embolization with polyvinyl alcohol particles (PVA).

Placebos

Intervention Type: DRUG

intravenous injection every 2 weeks

Interventions

TACE

Hepatic intra-arterial infusion with lipiodol mixed with chemotherapy drugs (EADM, lobaplatin, and MMC), and embolization with polyvinyl alcohol particles (PVA).

Intervention Type: PROCEDURE

PD-1 antibody

3mg/kg intravenously every 2 weeks

Intervention Type: DRUG

Placebos

intravenous injection every 2 weeks

Intervention Type: DRUG

Other Intervention Names

normal saline

Eligibility Criteria

Inclusion Criteria

• KPS≥70;
• The diagnosis of HCC was based on the diagnostic criteria for HCC used by the European Association for the Study of the Liver (EASL), simultaneously staged as BCLC A or BCLC B based on Barcelona Clinic Liver Cancer staging system.
• Patients must have at least one tumor lesion that can be accurately measured;
• Diagnosed as unresectable with consensus by the panel of liver surgery experts;
• Re commanded treated by TACE with consensus by the panel of liver MDT;
• No past history of TACE, chemotherapy or molecule-targeted treatment;
• No Cirrhosis or cirrhotic status of Child-Pugh class A only
• Meet the following laboratory parameters:(a) Platelet count ≥ 75,000/μL; (b)Hemoglobin ≥ 8.5 g/dL;(c) Total bilirubin ≤ 30mmol/L;(d) Serum albumin

≥ 32 g/L;(e) ASL and AST ≤ 6 x upper limit of normal;(f) Serum creatinine

≤ 1.5 x upper limit of normal;(g) INR > 2.3 or PT/APTT within normal limits; (h) 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

• Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
• Known of serious heart disease which can nor endure the treatment such as cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
• 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.
• Evidence of bleeding diathesis.
• Any other hemorrhage/bleeding event > CTCAE Grade 3 within 4 weeks of first dose of study drug
• Serious non-healing wound, ulcer, or bone fracture
• Known central nervous system tumors including metastatic brain disease
• Poor compliance that can not comply with the course of treatment and follow up.

• 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

Proffessor

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 Hospital

Guangzhou, Guangdong, China

Kaiping Central Hospital

Kaiping, Guangdong, China

Countries

China

Other Identifiers

HCC-S066

Identifier Type: -

Identifier Source: org_study_id