A study to investigate the safety, tolerability and efficacy of PCI/Gemcitabine treatment followed by combination chemotherapy in patients with cholangiocarcinomas

Mise à jour : Il y a 4 ans
Référence : EUCTR2012-002888-10

Femme et Homme

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Extrait

Phase I Dose Escalation • To determine a tolerable dose and safety profile of Amphinex-induced PCI of gemcitabine followed by systemic gemcitabine/cisplatin chemotherapy in patients with advanced inoperable cholangiocarcinoma Extended Part of Phase I • To determine the tolerability and safety profile of a two-administration schedule of Amphinex-induced PCI of gemcitabine followed by systemic gemcitabine/cisplatin chemotherapy in patients with advanced inoperable cholangiocarcinoma Phase II • To make a preliminary assessment of the efficacy of Amphinex-induced PCI of gemcitabine followed by systemic gemcitabine/cisplatin chemotherapy in patients with advanced inoperable cholangiocarcinoma


Critère d'inclusion

  • Inoperable advanced cholangiocarcinomas