Evaluation of Hepatic Arterial Infusion of Cisplatin and 5-FU in Biomarker Stratified HCC

• Status: Unknown status
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is to assess the efficacy and the safety of hepatic arterial infusion of cisplatin and 5-fluorouracil (HAIC) in advanced HCC patients stratified by biomarker expression predicting therapeutic response.

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

Details

• Lead Sponsor: CbsBioscience
• Treatments: Cisplatin; Fluorouracil

Criteria

Inclusion Criteria:

• over 20 years old

• Patients with advanced hepatocellular carcinoma who have progressed or intolerance to Sorafenib

• Patients with advanced hepatocellular carcinoma who cannot be treated with surgery, transplantation, RFA, or TACE.

• TNM stage III/IV (including intrahepatic single or multiple tumors without extrahepatic metastasis regardless of lymph node metastasis)

• ECOG performance status of 0 or 1

• Liver function status of Child-Pugh Class A or B

• more than 3 months of life expectancy

• serum creatinine <1.5 mg/dL

• aminotransferase <5 times the upper limit of normal

• absolute neutrophil count >1,500 cells/lL

• platelet count >75,000/lL

• hemoglobin >10 g/dL

Exclusion Criteria:

• patients with extrahepatic tumors

• Patients requiring combined treatment with chemotherapy, radiotherapy, TACE, RFA, or others

• Patients in any severe and/or uncontrolled medical conditions

• patients with history of allergic response to CT contrast media

• patients who participated as subjects in other interventional clinical studies (as of the date of visit) within 60 days before drug administration

• Any person deemed inappropriate by reason of the investigator for other reasons