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

Update Il y a 4 ans
Reference: EUCTR2012-002888-10

Woman and Man

  • | Country :
  • -
  • | organs :
  • -
  • | Specialty :
  • -

Extract

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


Inclusion criteria

  • Inoperable advanced cholangiocarcinomas