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

Launched by SUN YAT-SEN UNIVERSITY · Dec 19, 2018

Keywords

ClinConnect Summary

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.

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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.