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| ID | Type | Description | Link |
|---|---|---|---|
| A5961080 |
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To evaluate the safety and efficacy of irinotecan and capecitabine in Asian subjects with inoperable hepatocellular carcinoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Irinotecan plus capecitabine | Drug | Irinotecan 200-250 mg/m2 intravenous infusion over 30 to 90 minutes on day 1 of a 3-week cycle. Capecitabine 1000 mg/m2 oral tablet twice daily for 14 days followed by a 7 day rest throughout the treatment period for |
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate | Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Shanghai | 200433 | China | |||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| 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 |
| Hong Kong SAR |
| Hong Kong |
| Pfizer Investigational Site | Seoul | 135-710 | South Korea |
| Pfizer Investigational Site | Seoul | 136-705 | South Korea |
| Pfizer Investigational Site | Seoul | 138-736 | South Korea |
| Pfizer Investigational Site | Seoul | 152-703 | South Korea |
| Pfizer Investigational Site | Keelung | 204 | Taiwan |
| Pfizer Investigational Site | Taipei | 112 | Taiwan |
| Pfizer Investigational Site | Taipei | Taiwan |
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
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| ID | Term |
|---|---|
| D000077146 | Irinotecan |
| D000069287 | Capecitabine |
| ID | Term |
|---|---|
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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