Safety And Efficacy Of Irinotecan Plus Capecitabine As First-Line Treatment In Asian Subjects With Hepatocellular Carcinoma
- Registration Number
- NCT00635323
- Lead Sponsor
- Pfizer
- Brief Summary
To evaluate the safety and efficacy of irinotecan and capecitabine in Asian subjects with inoperable hepatocellular carcinoma.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 73
Inclusion Criteria
- Asian subjects with histologically or cytologically confirmed hepatocellular carcinoma
- Inoperable disease (unable to completely remove surgically, presence of extra-hepatic disease, main portal vein or hepatic vein involvement)
- Eastern Cooperative Oncology Group performance status of ?2
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Exclusion Criteria
- Decompensated cirrhosis or stage C (Index>10) according to the Child-Pugh Classification
- Current history of chronic diarrhoea
- Reproductive potential not using adequate contraceptive measures
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description A Irinotecan plus capecitabine -
- Primary Outcome Measures
Name Time Method Overall response rate Week 6
- Secondary Outcome Measures
Name Time Method Time to progression Weeks 6, 12, 18, 24, 36, and 1 year Duration of overall response Weeks 6, 12, 18, 24, 36, and 1 year Overall tumour growth control rate Weeks 6, 12, 18, 24, 36, and 1 year Overall survival Weeks 6, 12, 18, 24, 36, and 1 year Adverse events Weeks 6, 12, 18, 24, 36, and 1 year Physical exam Weeks 6, 12, 18, 24, 36, and 1 year Laboratory tests Weeks 6, 12, 18, 24, 36, and 1 year
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇨🇳Taipei, Taiwan