Status:
WITHDRAWN
HAIC Plus PD-1 Antibody vs HAIC Plus Sorafenib for Advanced 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 hepatic artery infusion chemotherapy (HAIC) combined with Programmed Cell Death Protein-1 (PD-1) antibody compared with HAIC plus so...
Detailed Description
The results of our preliminary pilot study suggested that sorafenib combined with hepatic arterial infusion chemotherapy (HAIC) may improve the survivals for advanced hepatocellular (HCC). Programmed ...
Eligibility Criteria
Inclusion
- 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
- Major portal vein tumor thrombus (Vp3,Vp4)
- Eastern Cooperative Oncology Group performance status of 0 to 1
- 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:
- Platelet count ≥ 75,000/μL
- 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
- 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
Key Trial Info
Start Date :
April 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03780634
Start Date
April 1 2019
End Date
December 1 2021
Last Update
May 6 2019
Active Locations (3)
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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