D07001 Softgel-Capsules and Capecitabine Combination Therapy in Patients With Advanced Biliary Tr… (NCT06622057) | Clinical Trial Compass
Not Yet RecruitingPhase 3
D07001 Softgel-Capsules and Capecitabine Combination Therapy in Patients With Advanced Biliary Tract Cancer
Taiwan195 participantsStarted 2026-05-01
Plain-language summary
The object of this trial is to evaluate the efficacy of D07001-softgel capsules + capecitabine compared with placebo + capecitabine by overall survival (OS).
Eligible patients with advanced biliary tract cancer (BTC) will be randomized (1:1:1) to receive either 60 mg D07001-softgel, 100 mg D07001-softgel, or placebo, combine with capecitabine. Treatment will be continued until disease progression, death, withdraw consent, or completing 12 treatment cycles , whichever occurs first.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Provide written informed consent prior to any study procedures and agree to adhere to all protocol requirements
✓. Aged at least 18 years.
✓. Has histopathological or cytologic diagnosis of unresectable, locally advanced or metastatic BTC.
✓. Has measurable disease as assessed by RECIST v1.1.
✓. Must have failed on a gemcitabine + cisplatin-based chemotherapy, regardless of whether immune checkpoint inhibitor, such as durvalumab or pembrolizumab, or S-1 (tegafur, gimeracil, and oteracil potassium), was also administered. Oxaliplatin or carboplatin may be substituted for cisplatin when renal or auditory function is of concern. Participants also have failed (disease progression or intolerance) on, or refused FOLFOX chemotherapy, including modified FOLFOX variants, or failed on or irinotecan + fluorouracil chemotherapy.
✓. Participants with tumors expressing the following biomarkers can be enrolled if they have not previously received FOLFOX but have received appropriate targeted therapies until disease progression or intolerance: fibroblast growth factor receptors aberrations, microsatellite instability biomarker/deficient DNA mismatch repair, or isocitrate dehydrogenase mutations.
✓. ECOG PS of 0-2.
✓. Life expectancy is ≥12 weeks.
Exclusion criteria
✕. Has a diagnosis of active malignancy other than BTC within the past 2 years, except nonmelanoma skin carcinoma and carcinoma-in-situ of uterine cervix treated with curative intent.
What they're measuring
1
Overall Survival (OS)
Timeframe: From date of randomization until the date of death, assessed up to 2 years
. Participant discontinued prior gemcitabine due to pulmonary or hepatic toxicity or hemolytic uremic syndrome, hypersensitivity, allergic reaction, or intolerance.
✕. Participant had a prior unanticipated severe reaction to capecitabine or metabolites or to fluoropyrimidine therapy.
✕. Participant received treatment with brivudine, sorivudine, or its chemically related analogs ≤28 days prior to the date of enrollment.
✕. Participant is currently receiving flucytosine treatment.
✕. Participant has residual toxicity from prior chemotherapy or CCRT that is Grade ≥2 (residual Grade 2 neuropathy and alopecia are permitted).
✕. Participant has any gastrointestinal disorder or prior gastrointestinal surgery that would significantly impede absorption of an oral agent, such as gastrectomy, Crohn's disease, ulcerative colitis, or short gut syndrome.
✕. Participant has known brain or leptomeningeal metastases.