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

NCT03782831 | Withdrawn Phase 2 DMC

• 1 other identifier: HCC-S066
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 3

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)

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular carcinoma; Programmed cell death protein-1 antibody; Transarterial chemoembolization

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS)

  PFS was defined as the time from the date of randomization to the date of first documentation of disease progression based on modified Response Evaluation Criteria in Solid Tumors (mRECIST), or date of death, whichever occurred first.

  12 months

Secondary Outcomes (3)

• Overall Survival (OS)

  12 months

• Objective Response Rate (ORR)

  12 months

• Adverse Events

  12 months

Study Arms (2)

TACE plus PD-1 antibody

EXPERIMENTAL

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.

Procedure: TACE; Drug: PD-1 antibody

TACE alone

ACTIVE COMPARATOR

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

Procedure: TACE; Drug: Placebos

Interventions

TACE PROCEDURE

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

TACE alone; TACE plus PD-1 antibody

PD-1 antibody DRUG

3mg/kg intravenously every 2 weeks

TACE plus PD-1 antibody

Placebos DRUG

intravenous injection every 2 weeks

Also known as: normal saline

TACE alone

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead
• Kaiping Central Hospital: collaborator
• Guangzhou No.12 People's Hospital: collaborator

Study Sites (3)

Cancer Center Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

Location

Guangzhou Twelfth People's Hospital

Guangzhou, Guangdong, 510620, China

Location

Kaiping Central Hospital

Kaiping, Guangdong, 529300, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

spartalizumab; Saline Solution

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Ming Shi, MD

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Proffessor

Study Record Dates

• First Submitted: December 19, 2018
• First Posted: December 20, 2018
• Study Start: December 11, 2018
• Primary Completion: December 1, 2019
• Study Completion: June 1, 2020
• Last Updated: May 2, 2019

Record last verified: 2018-12

Locations

CN (3)