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 (Jun 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
Treatments studied
Other
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.
Frequently asked questions
Is NCT05065957 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior chemotherapy regimen other than first line gemcitabine and cisplatin-based therapy, chemotherapy disqualifies patients from enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages