NCT06274879 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Kelley RK, Ueno M, Yoo C, Finn RS, Furuse J, Ren Z, Yau T, Klumpen HJ, Chan SL, Ozaka M, Verslype C, Bouattour M, Park JO, Barajas O, Pelzer U, Valle JW, Yu L, Malhotra U, Siegel AB, Edeline J, Vogel A; KEYNOTE-966 Investigators
Pembrolizumab in combination with gemcitabine and cisplatin compared with gemcitabine and cisplatin alone for patients with advanced biliary tract cancer (KEYNOTE-966): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2023 Jun 3;401(10391):1853-1865. doi: 10.1016/S0140-6736(23)00727-4. Epub 2023 Apr 16. Erratum In: Lancet. 2023 Sep 16;402(10406):964. Lancet. 2024 Mar 23;403(10432):1140.
Rimini M, Fornaro L, Lonardi S, Niger M, Lavacchi D, Pressiani T, Lucchetti J, Giordano G, Pretta A, Tamburini E, Pirrone C, Rapposelli IG, Diana A, Martinelli E, Garajova I, Simionato F, Schirripa M, Formica V, Vivaldi C, Caliman E, Rizzato MD, Zanuso V, Nichetti F, Angotti L, Landriscina M, Scartozzi M, Ramundo M, Pastorino A, Daniele B, Cornara N, Persano M, Gusmaroli E, Cerantola R, Salani F, Ratti F, Aldrighetti L, Cascinu S, Rimassa L, Antonuzzo L, Casadei-Gardini A
Durvalumab plus gemcitabine and cisplatin in advanced biliary tract cancer: An early exploratory analysis of real-world data. Liver Int. 2023 Aug;43(8):1803-1812. doi: 10.1111/liv.15641.

Safety of Biliary Intraductal Radiofrequency Ablation in Patients With Unresectable Extrahepatic Biliary Tract Cancer Undergoing Standard of Care Chemo-immune Checkpoint Inhibitor -Therapy: a Phase II, Multicenter, Randomized and Controlled

Details for clinical trial NCT06274879

Clinical trial NCT06274879 - References