A phase 1 study of combination chemotherapy for hepatocellular carcinoma using Miripla® (SM11355) and IA-call® (DDP-H)
Phase 1
- Conditions
- Hepatocellular carcinoma
- Registration Number
- JPRN-UMIN000003541
- Lead Sponsor
- iigata Hepatocellular Carcinoma Therapy Study Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 18
Inclusion Criteria
Not provided
Exclusion Criteria
1) Pleural effusion and/or ascites refractory to treatments. 2) Comorbidity: Active infectious diseases except for hepatitis. Active bleeding from GI tract. Active concomitant cancer with invasive nature. Severe mental disorder or hepatic encephalopathy. 3) A history of severe allergic reaction against iodine contrast medium and/or platinum agents. 4) A pregnant or lactating female or female of childbearing age unless using effective contraception. 5) Ongoing interferon therapy. 6) Difficulties of oral intake. 7) Other serious conditions judged to be inadequate by a responsible doctor.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1) CBC, Coagulation factors 2) Basic biochemistry (TP, Alb, AST, ALT, ALP, LDH, GTP, T.Bil, D.Bil, BUN, Crt, Na, K, Cl, CRP) 3) Specific biochemistry (ChE, T.Chol, TG, HbA1c, NAG, beta-2-microgloblin) 4) Urinalysis 5) Retention time of ICG, Ccr
- Secondary Outcome Measures
Name Time Method 1) Tumor marker (AFP, Fucosylated fraction of AFP, DCP) 2) Imaging evaluation of hepatocellular carcinoma 3) Serum concentratio of platinum