Clinical trial · Interventional
Phase II Study of Gemcitabine Versus S-1 Adjuvant Therapy After Hemihepatectomy for Biliary Tract Cancer
Randomized Phase II Study of Gemcitabine Versus S-1 Adjuvant Therapy After Hemihepatectomy for Biliary Tract Cancer
NCT01815307CI-TRIAL-00032952completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To compare efficacy and safety of Gemcitabine versus S-1 adjuvant therapy after hemihepatectomy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Biliary Tract Cancer | Malignant Biliary Tract Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| S-1 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Gemcitabine group
- description
- 1000mg/m2, day 1 every 2 weeks
- interventionNames
- Drug: Gemcitabine
- type
- EXPERIMENTAL
- label
- S-1 group
- description
- 80mg/m2/day, day 1-28, every 6 weeks
- interventionNames
- Drug: S-1
Primary outcomes (1)
- measure
- 1 year recurrent free survival rate
- timeFrame
- One year
- description
- Duration: From randomization to evidenced recurrence or death. Rate: Number of patients with evidenced recurrence or death / number of total patients. 1 year recurrent free survival rate: recurrent free survival rate at one-year from the randomization
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: 1. Biliary tract cancer (BTC) (\>= Unio Internationalis Contra Cancrum (UICC) Stage IB), adenocarcinoma 2. R0 or R1 resection 3. no obvious recurrent lesion 4. 20 years old or more 5. Eastern Cooperative Oncology Group (ECOG) performance status must be 0 or 1 6. The patient underwent no other treatment than surgery for BTC 7. Neutrophil must be over 1500/μl, Hemoglobin must be over 9.0g/dL, platelet must be over 100,000/μl, Aspartate transaminase (AST) and Alanine aminotransferase (ALT) must be less than 150 IU/L, total bilirubin must be less than 1.5 mg/dL, Creatinine must be less than 1.2 mg/dl, and Creatinine clearance must be over 60 mL/min 8. The patient can intake drugs per os. 9. From 4 to 12 weeks after the surgery 10. Written informed consent Exclusion Criteria: 1. Existence of active double cancer 2. The patient suffered from severe drug allergy 3. Sever complications (interstitial pneumonia, heart failure, renal failure, liver failure, ileus, incontrollable diabetes mellitus, and so on) 4. Any active infections exist. 5. Pregnancy 6. Severe mental disorder 7. Others
References
Publications (0)
Data not yet available
No reference posted for this study.