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The purpose of this study is to assess the difference of safety and efficacy about Capecitabine and S-1 for treatment of patients with low-risk of recurrence after BTC surgery.
Patients received curative BTC surgery will be informed about the study. After being informed about the study and potential risks, all patients giving written informed consent will undergo a 1-week screening period to determine eligibility for study entry. At week 0, patients who meet the eligibility requirements will be observed for recurrence of BTC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cape Group | In this group, capecitabine was administered at a dose of 1250 mg/m² bid on 14 days of a tri-weekly cycle for 8 cycles. |
| |
| S-1 Group | In this group, S-1 was administered at a dose of 80-120 mg/day on 14 days of a tri-weekly cycle for 8 cycles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| S-1 | Drug | S-1 was administered at a dose of 80-120 mg/day on 14 days of a tri-weekly cycle for 8 cycles. |
|
| Measure | Description | Time Frame |
|---|---|---|
| RFS, recurrence-free survival | RFS was counted from the enrollment to the date on which disease progression or death was detected, or was censored on the last date when progression-free status was confirmed. | Enrollment to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| OS, overall survival | OS was calculated from the enrollment to the date of death, or censored on the date of last contact for surviving patients. | Enrollment to 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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Patients have received curative surgery of pathological diagnosed gallbladder cancer or bile duct cancer.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Haoting Sun, M.D. | Contact | 13917700105 | sunh09@fudan.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huashan hospital | Recruiting | Shanghai | 200040 | China |
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| ID | Term |
|---|---|
| D001661 | Biliary Tract Neoplasms |
| D012008 | Recurrence |
| D018281 | Cholangiocarcinoma |
| D005706 | Gallbladder Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001660 | Biliary Tract Diseases |
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| ID | Term |
|---|---|
| C079198 | S 1 (combination) |
| D005641 | Tegafur |
| D000069287 | Capecitabine |
| ID | Term |
|---|---|
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 |
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tumor specimen of surgery
| Capecitabine | Drug | Capecitabine was administered at a dose of 1250 mg/m² bid on 14 days of a tri-weekly cycle for 8 cycles. |
|
|
| D004066 |
| Digestive System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D005705 | Gallbladder Diseases |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |