At a glance
ClinicalIndex Comparison Record- ✓Histopathological or cytologic diagnosis of unresectable metastatic or locally advanced BTC
- ✓Failed first-line gemcitabine and cisplatin-based chemotherapy
- ✓Age 18 years or older (20 or older in Taiwan)
- ✓Life expectancy >12 weeks
- ✕Prior chemotherapy other than first-line gemcitabine-cisplatin
- ✕Active malignancy other than BTC within past 2 years
- ✕Prior discontinuation of gemcitabine due to pulmonary/hepatic toxicity, HUS, or hypersensitivity
- ✕Known hypersensitivity to capecitabine, tegafur, gimeracil, oteracil potassium, oxaliplatin, platinum compounds, leucovorin, folic acid, or 5-fluorouracil
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Open-Label, Multicenter, Phase II/III Study of Combination Therapy of D07001-Softgel Capsules and Xeloda/TS-1 in Subjects With Advanced Biliary Tract Cancer After Gemcitabine and Cisplatin-Based Treatment Failure
In Brief
A Phase 3 clinical trial evaluating D07001-softgel capsules + Xeloda (or TS-1) and mFOLFOX for Biliary Tract Cancer. Currently recruiting, targeting 180 participants across 5 sites.
Detailed Summary
The primary objective are: To assess the safety and tolerability of the combination of D07001-softgel capsules and Xeloda/TS-1. To evaluate the efficacy of the combination of D07001-softgel capsules and Xeloda/TS-1, as assessed by disease control rate (DCR).
Study Details
Timeline
Interventions
D07001-softgel capsules: 3 times per week (on Days 1, 3, 5, 8, 10, 12, 15, 17, and 19 of a 21-day cycle, 9 doses per cycle). Xeloda (or TS-1): twice daily for 14 consecutive days followed by 7 days rest (1 treatment cycle)
intravenous infusion on Day 1 for 14-day cycle