Immunotherapy With Durva and Treme With or Without Capecitabine in Adjuvant Treatment for Biliary… (NCT05239169) | Clinical Trial Compass
CompletedPhase 2
Immunotherapy With Durva and Treme With or Without Capecitabine in Adjuvant Treatment for Biliary Tract Cancer
Germany40 participantsStarted 2022-05-23
Plain-language summary
This is an interventional, prospective multicenter, open-label, phase II study in patients after curative surgery for BTC in a classic adjuvant situation, consisting of a two arm feasibility pilot part with a randomized pick-the-winner design and an option to proceed into a randomized phase 2/3 trial in order to compare the winner with the current SOC (capecitabine).
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
. Capable of giving written informed consent, including participation in optional translational research if applicable, and any locally-required authorization (EU Data Privacy Directive in the EU) obtained from the subject prior to performing any protocol-related procedures, including screening evaluations.
. Histologically proven and curatively resected biliary tract cancer (intrahepatic, hilar or distal CCA as well gallbladder carcinoma) without metastatic disease, in the adjuvant situation (R0/R1) up to 16 weeks from surgery.
. Men or women\* ≥ 18 years at time of study entry.
. Performance status (PS) ≤ 1 (ECOG scale),with no deterioration over the previous two weeks prior to baseline.
. Must have a life expectancy of at least 12 weeks
. Appropriate hematological, hepatic and renal function:
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 trial tested durvalumab and tremelimumab — two immunotherapy drugs — with or without the chemotherapy pill capecitabine after surgery for biliary tract cancer; can you explain what combining checkpoint inhibitors with or without capecitabine might mean for my specific type, and whether that approach makes sense for my situation?
2The trial measured whether patients were recurrence-free at 12 months — since this was a Phase 2 study that has now completed, has any data been published yet, and what did the results suggest about the risk of cancer coming back compared to standard follow-up care after surgery?
3Because this is a Phase 2 trial, the evidence on long-term safety and benefit is still limited compared to approved standard treatments — given that, do you think I should consider a standard adjuvant chemotherapy regimen like capecitabine alone first, or would this immunotherapy approach be worth discussing as an option?
4The trial enrolled people with several different biliary tract cancers, including intrahepatic, hilar, and distal cholangiocarcinoma as well as gallbladder carcinoma — does my specific diagnosis and surgical outcome put me in a group that might respond differently to this kind of immunotherapy combination?
5Tremelimumab and durvalumab both work on the immune system and can cause serious immune-related side effects — based on my overall health and how I recovered from surgery, do you think my body would be able to handle that kind of treatment safely?
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
Recurrence free survival at 12 months (RFS@12).
Timeframe: 12 months
Trial details
NCT IDNCT05239169
SponsorInstitut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
. Adequate coagulability, as determined by the International Normalized Ratio (INR) ≤ 1.5 and partial thromboplastin time (PTT) ≤ 5 seconds above the UNL (unless anti-coagulation therapy has been given). Patients receiving warfarin / phenoprocoumon must be switched to low molecular weight heparin and before starting study-specific procedures.
. Patients of reproductive age must be prepared to use a suitable contraceptive method during the study and up to 3 months after the end of treatment. A suitable method of contraception is defined as surgical sterilization (e.g., bilateral fallopian tube ligation, vasectomy), hormonal contraception (implantable, patch, oral), and double barrier methods (each two-fold combination of intrauterine pessary, condom for men, or women with spermicidal gel, Diaphragm, contraceptive sponge, cervical cap). Women of child-bearing potential must have a negative serum pregnancy test within the last 7 days prior to the start of study therapy.
Exclusion criteria
. Presence of tumors other than biliary tract cancer or a secondary tumor other than squamous or basal cell carcinomas of the skin or in situ carcinomas of the cervix which have been effectively treated. Patients who have received curative treatment for other tumors and have been disease-free for at least 5 years at the time of screening are eligible for enrollment.
. Metastatic biliary tract cancer disease.
. Simultaneous, ongoing systemic immunotherapy, chemotherapy, or hormone therapy not described in the study protocol.
. Simultaneous treatment with a different anti-cancer therapy other than that provided for in the study (excluding palliative radiotherapy only for symptom control)
. Previous therapy with a PD-1, PD-L1 inhibitor (including durvalumab) or CTLA4 inhibitor (including tremelimumab) or classical chemotherapy agents like platinum, fluoropyrimidine or gemcitabine based regimens.
. Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria
. Stage B cirrhosis according to Child-Pugh criteria (or worse) or cirrhosis (of any grade) with a history of hepatic encephalopathy or clinically significant ascites resulting from cirrhosis. Clinically significant ascites is defined as ascites resulting from cirrhosis requiring diuretics or paracentesis.
. Known allergic / hypersensitive reactions to at least one of the treatment components.