Clinical trial NCT03782831: TACE Plus PD-1 Antibody vs TACE Alone for Unresectable HCC
Official title: Transarterial Chemoembolization Plus Programmed Cell Death Protein-1 Antibody Versus Transarterial Chemoembolization Alone for Unresectable Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Hepatocellular Carcinoma
Keywords: Hepatocellular carcinoma
Programmed cell death protein-1 antibody
Transarterial chemoembolization
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Kaiping Central Hospital
name: Guangzhou No.12 People's Hospital
First posted: 2018-12-20
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: 12 months
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: 12 months
measure: Objective Response Rate (ORR)
timeFrame: 12 months
measure: Adverse Events
timeFrame: 12 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Cancer Center Sun Yat-sen University
state: Guangdong
city: Guangzhou
country: China
facility: Guangzhou Twelfth People's Hospital
state: Guangdong
city: Kaiping
country: China
facility: Kaiping Central Hospital
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Ming Shi, MD
role: PRINCIPAL_INVESTIGATOR
References: