D07001 Softgel-Capsules and Capecitabine Combination Therapy in Patients With Advanced Biliary Tr… (NCT06622057) | Clinical Trial Compass
RecruitingPhase 3
D07001 Softgel-Capsules and Capecitabine Combination Therapy in Patients With Advanced Biliary Tract Cancer
United States, Taiwan195 participantsStarted 2026-06-09
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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Provide written informed consent prior to any study procedures and agree to adhere to all protocol requirements.
. Participant aged at least 18 years at the time of consent.
. Participant has histopathological or cytologic diagnosis of unresectable, locally advanced or metastatic BTC (cholangiocarcinoma, gallbladder cancer, or ampullary carcinoma).
. Participant has measurable disease as assessed by central review by RECIST v1.1.
. Participant must have failed on a gemcitabine + cisplatin-based chemotherapy, regardless of whether an 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 irinotecan + fluorouracil-based chemotherapy.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This is a Phase 3 trial, which means it's testing whether D07001 softgel capsules combined with capecitabine actually extends survival compared to existing options — can you help me understand what the earlier phases showed about safety and effectiveness before this larger study started?
2The primary thing this trial is measuring is overall survival, so patients need to stay in the study long-term — realistically, how would the visit schedule, treatment regimen, and monitoring requirements fit into my day-to-day life?
3Since this trial is specifically for advanced biliary tract cancer, is my particular diagnosis and stage the right match for what they're enrolling, and are there any other criteria that might affect whether this is even an option worth discussing further?
4Capecitabine is already used in some biliary tract cancer treatments — what would I potentially be gaining by adding D07001 softgel capsules to it in this trial, compared to receiving a proven standard-of-care regimen on its own?
5If I were to discuss joining this trial with you, what would I be giving up or delaying in terms of other established treatments, and is there a reason you'd recommend trying standard therapy first before considering an experimental combination like this?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Overall Survival (OS)
Timeframe: From date of randomization until the date of death, assessed up to 2 years
. Participants with tumors expressing the following biomarkers may be enrolled even if they have not previously received FOLFOX but have received appropriate targeted therapies until disease progression or intolerance: fibroblast growth factor receptors (FGFR) aberrations, microsatellite instability biomarker/deficient DNA mismatch repair, Tumor Mutation Burden-high, or mutations in isocitrate dehydrogenase, BRAF, HER2, NTRK, RET, or KRAS G12C.
. Participant has ECOG PS of 0-2.
. Participant's life expectancy is ≥12 weeks.
Exclusion criteria
. Participant 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.
. 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.