OncoMatch/Clinical Trials/NCT05065957
Study of Combination Therapy of D07001-Softgel Capsules and Xeloda/TS-1 in Subjects With Advanced Biliary Tract Cancer
Is NCT05065957 recruiting? Yes, currently enrolling (May 2026). This Phase 2/3 trial studies multiple treatments including D07001-softgel capsules + Xeloda (or TS-1) and mFOLFOX for biliary tract cancer.
Treatment: D07001-softgel capsules + Xeloda (or TS-1) · mFOLFOX — 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).
Check if I qualifyExtracted eligibility criteria
Cancer type
Cholangiocarcinoma
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: gemcitabine and cisplatin-based chemotherapy (gemcitabine, cisplatin) — first-line
Subject must have failed from first line gemcitabine and cisplatin-based chemotherapy
Cannot have received: chemotherapy regimen other than first line gemcitabine and cisplatin-based therapy
Exception: prior fluoropyrimidine base (including capecitabine, carmofur (HCFU), doxifluridine, fluorouracil (5-FU), and tegafur) chemotherapy as postsurgical adjuvant therapy allowed
Have prior chemotherapy regimen other than first line gemcitabine and cisplatin-based therapy for unresectable metastatic or locally advanced BTC. Note: prior fluoropyrimidine base (including capecitabine, carmofur (HCFU), doxifluridine, fluorouracil (5-FU), and tegafur) chemotherapy (including fluoropyrimidine monotherapy or combination therapy) are allowed as postsurgical adjuvant therapy.
Cannot have received: chemotherapy
Subject has not received other chemotherapy since first-line treatment
Lab requirements
Blood counts
anc ≥1,500 cell/mm3; platelet count ≥ 100,000 cells/mm3; hemoglobin ≥ 9 g/dl
Kidney function
serum creatinine ≤1.5 x uln; creatinine clearance ≥ 50ml/min calculated by cockcroft-gault formula or egfr ≥ 50ml/min/1.73m2 by 2021 ckd-epi creatinine equation
Liver function
ast and alt ≤2.5 x uln, or ≤5.0 x uln in the case of liver metastases; total bilirubin ≤1.5 x uln; albumin ≥3.0 g/dl; inr <1.5
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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