Phase Ⅱ Study of HAIC of FOLFOX vs. Sorafenib in HCC Refractory to TACE

• Status: Recruiting
• Trial end date: 2021-03-22
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate safety and efficacy of combined hepatic arterial infusion chemotherapy (HAIC) of oxaliplatin, 5-fluorouracil and leucovorin and sorafenib in hepatocellular carcinoma (HCC) refractory to transarterial chemoembolization(TACE)

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University
• Collaborators: First Affiliated Hospital, Sun Yat-Sen University; Guangzhou No.12 People's Hospital; Kaiping Central Hospital
• Treatments: Fluorouracil; Leucovorin; Niacinamide; Oxaliplatin; Sorafenib

Criteria

Inclusion Criteria:

• TACE failure or refractoriness based on the Liver Cancer Study Group of Japan (LCSGJ) criteria, including appearance of vascular invasion or two or more consecutive insufficient responses of the intrahepatic lesion;

• Except for TACE, patients have received no previous anti-tumor treatment;

• The diagnosis of HCC was based on histological results;

• Patients must have at least one tumor lesion that can be accurately measured;

• Not amendable to surgical resection ,local ablative therapy and any other cured treatment;

• No Cirrhosis or cirrhotic status of Child-Pugh class A only;

• No liver protection therapy in 2 weeks before enrolled, and 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 ≤ 5 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:

• 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;

• Any other hemorrhage/bleeding event > CTCAE Grade 3 within 4 weeks of first dose of study drug.