Status:
WITHDRAWN
TACE Plus PD-1 Antibody vs TACE Alone for Unresectable HCC
Lead Sponsor:
Sun Yat-sen University
Collaborating Sponsors:
Kaiping Central Hospital
Guangzhou No.12 People's Hospital
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 pat...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 11 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03782831
Start Date
December 11 2018
End Date
June 1 2020
Last Update
May 2 2019
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Cancer Center Sun Yat-sen University
Guangzhou, Guangdong, China, 510060
2
Guangzhou Twelfth People's Hospital
Guangzhou, Guangdong, China, 510620
3
Kaiping Central Hospital
Kaiping, Guangdong, China, 529300