Dokument: Study protocol of an open-label, single arm phase II trial investigating the efficacy and safety of Trifluridine/Tipiracil combined with irinotecan as a second line therapy in patients with cholangiocarcinoma (TRITICC)

Titel:Study protocol of an open-label, single arm phase II trial investigating the efficacy and safety of Trifluridine/Tipiracil combined with irinotecan as a second line therapy in patients with cholangiocarcinoma (TRITICC)
URL für Lesezeichen:https://docserv.uni-duesseldorf.de/servlets/DocumentServlet?id=67466
URN (NBN):urn:nbn:de:hbz:061-20241112-104155-1
Kollektion:Publikationen
Sprache:Englisch
Dokumententyp:Wissenschaftliche Texte » Artikel, Aufsatz
Medientyp:Text
Autoren: Kehmann, Linde [Autor]
Berres, Marie-Luise [Autor]
Gonzalez-Carmona, Maria [Autor]
Modest, Dominik P. [Autor]
Mohr, Raphael [Autor]
Wree, Alexander [Autor]
Venerito, Marino [Autor]
Strassburg, Christian [Autor]
Keitel, Verena [Autor]
Trautwein, Christian [Autor]
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Dateien vom 12.11.2024 / geändert 12.11.2024
Stichwörter:Irinotecan, Chemotherapy, Second-line treatment, FTD/TPI (Trifluridine/Tipiracil), Biliary tract cancer, Gall bladder carcinoma, Cholangiocarcinoma, Translational research
Beschreibung:Background
The prognosis of patients with advanced biliary tract cancer (BTC) who have progressed on gemcitabine plus cisplatin is dismal. Trifluridine/tipiracil (FTD/TPI) and irinotecan have proven efficacy in different gastrointestinal malignancies. We therefore hypothesized that this combination might improve the therapeutic outcome in patients with BTC after failure of first line treatment.

Methods
TRITICC is an interventional, prospective, open-label, non-randomised, exploratory, multicentre, single-arm phase IIA clinical trial done in 6 sites with expertise in managing biliary tract cancer across Germany. A total of 28 adult patients (aged ≥ 18 years) with histologically verified locally advanced or metastatic biliary tract cancer (including cholangiocarcinoma and gallbladder or ampullary carcinoma) with documented radiological disease progression to first-line gemcitabine based chemotherapy will be included to receive a combination of FTD/TPI plus irinotecan according to previously published protocols. Study treatment will be continued until disease progression according to RECIST 1.1 criteria or occurrence of unacceptable toxicity. The effect of FTD/TPI plus irinotecan on progression-free
survival will be analyzed as primary endpoint. Safety (according to NCI-CTCAE), response rates and overall survival are secondary endpoints. In addition, a comprehensive translational research program is part of the study and might provide findings about predictive markers with regard to response, survival periods and resistance to treatment.

Discussion
The aim of TRITICC is to evaluate the safety and efficacy of FTD/TPI plus irinotecan in patients with biliary
tract cancer refractory to previous Gemcitabine based treatment.
Rechtliche Vermerke:Originalveröffentlichung:
Kehmann, L., Berres, M.-L., Gonzalez-Carmona, M., Modest, D. P., Mohr, R., Wree, A., Venerito, M., Strassburg, C., Keitel, V., Trautwein, C., Lüdde, T., & Roderburg, C. (2023). Study protocol of an open-label, single arm phase II trial investigating the efficacy and safety of Trifluridine/Tipiracil combined with irinotecan as a second line therapy in patients with cholangiocarcinoma (TRITICC) [OnlineRessource]. BMC Cancer, 23, Article 470. https://doi.org/10.1186/s12885-023-10972-6
Lizenz:Creative Commons Lizenzvertrag
Dieses Werk ist lizenziert unter einer Creative Commons Namensnennung 4.0 International Lizenz
Fachbereich / Einrichtung:Medizinische Fakultät
Dokument erstellt am:12.11.2024
Dateien geändert am:12.11.2024
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