A phase 1 study of the combination chemotherapy of sorafenib with cisplatin transcatheter arterial infusion for advanced hepatocellular carcinoma.
Phase 1
- Conditions
- advanced hepatocellular carcinoma
- Registration Number
- JPRN-UMIN000001496
- Lead Sponsor
- ational Cancer Center Hospital
- Brief Summary
The combination of sorafenib at 800 mg/day with TAI of cisplatin at 65 mg/m2/cycle was determined to be the recommended regimen.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 21
Inclusion Criteria
Not provided
Exclusion Criteria
The exclusion criteria were history of chemotherapy with sorafenib or cisplatin, active infection, uncontrollable hypertension, severe heart disease, refractory pleural effusion or ascites, severe mental disorder or encephalopathy, active gastroduodenal ulcer or esophageal bleeding, active concomitant malignancy, pregnant and lactating females, females of childbearing age unless using effective contraception, and other serious medical conditions.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method dose-limiting toxicity, recommended dose, adverse events
- Secondary Outcome Measures
Name Time Method response rate, time to progression, overall survival