Clinical trial · Interventional
S-1 in Combination With Abraxane in Treating Cholangiocarcinoma
Phase II Study of Abraxane Plus S-1 as Second-line Treatment for Cholangiocarcinoma
NCT01963325CI-TRIAL-00031513completedPhase 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)
This phase II study was designed to evaluate the efficacy and safety of S-1 plus Abraxane as second-line treatment for cholangiocarcinoma.
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 |
|---|---|---|---|
| Cholangiocarcinoma | Cholangiocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| S-1 plus Abraxane | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- S-1 plus Abraxane
- description
- Patients will receive Abraxane at 100 mg/m2 X 3 doses on Days 1, 8. S-1 chemotherapy was given based on the body surface area, \<1.25 m2: 80mg/day, 1.25\~1.5 m2: 100mg/day, ≧1.5 m2: 120mg/day. Given orally twice daily for 14 days, followed by 7 days without treatment.
- interventionNames
- Drug: S-1 plus Abraxane
Primary outcomes (1)
- measure
- Response rates
- timeFrame
- 6 months
Secondary outcomes (2)
- measure
- Progression-free survival
- timeFrame
- 6 months
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Histologic or cytologic diagnosis of cholangiocarcinoma * Not eligible for curative surgery * Progressed after first-line gemcitabine-based chemotherapy * Eastern Cooperative Oncology Group (ECOG) performance status of 2 or better * No serious or uncontrolled concomitant medical illness * Adequate bone marrow function (absolute neutrophil count ≧1,500 ul, platelet count ≧90,000/ul), hemoglobin: \> or equal to 8 mg/dL, total bilirubin: \< or equal to 1.5 X institutional upper limit of normal, calculated creatinine clearance greater than or equal to 60 mL/min (calculated by the Cockcroft and Gault method). Exclusion Criteria: * Uncontrolled infection or severe active comorbid disease * Previous malignancy in the past five years, excluding nonmelanoma skin cancers and in situ cervical, bladder or uterine cancer * Pregnancy or lactating women
References
Publications (0)
Data not yet available
No reference posted for this study.