ADJUBIL: phase II study of adjuvant immunotherapy with STRIDE regimen with/without capecitabine in biliary tract cancers.
Thorsten GoetzeMaria A Gonzalez-CarmonaLisa KochenNihat Buğra AğaoğluSalah-Eddin Al-BatranTimorshah HabibzadaMiriam PonsMarius BrunnerThomas J EttrichClaus-Henning KöhneChristoph RoderburgDominik ModestPublished in: Future oncology (London, England) (2024)
Biliary tract cancer is a highly heterogeneous group of gastrointestinal cancers, and the only curative treatment is surgery, which is only applicable at early stages of the malignancy. ADJUBIL, a phase II trial (NCT05239169), aims to evaluate immunotherapy with durvalumab and tremelimumab with or without capecitabine in adjuvant situations for biliary tract cancers. A total of 40 prospective patients will be randomly assigned following surgery, consisting of a two-arm feasibility pilot part with a pick-the-winner design with durvalumab and tremelimumab in combination with or without capecitabine.
Keyphrases
- phase ii study
- open label
- locally advanced
- minimally invasive
- coronary artery bypass
- end stage renal disease
- early stage
- rectal cancer
- placebo controlled
- prognostic factors
- phase iii
- ejection fraction
- newly diagnosed
- chronic kidney disease
- metastatic breast cancer
- papillary thyroid
- study protocol
- peritoneal dialysis
- clinical trial
- surgical site infection
- childhood cancer
- double blind
- patient reported outcomes
- lymph node metastasis