834TiPA randomized controlled, open label, adaptive phase III Trial to evaluate safety and efficacy of endoTAG-1 plus gemcitabine versus gemcitabine alone in patients with measurable locally advanced and/or metastatic adenocarcinoma of the pancreas failed on FOLFIRINOX treatment

Abstract Background Pancreatic cancer (PC) is the 4th deadliest cancer in Europe, with more than 95% of those affected dying from the disease and is set to be the second greatest cause of death from cancer by 2020.(ECPC, European Cancer Patient Coalition) FOLFIRINOX regimen is the standard 1st-line treatment for PC patients with good performance status; however, there is still no standard of care in 2nd-line therapy for patients failed FOLFIRINOX. EndoTAG-1 is a novel formulation of cationic liposomes embedded with Paclitaxel, which specifically displays antivascular and antiangiogenic activity. By binding and internalizing at tumor endothelial cells after intravenous administration, the cytostatic and cytotoxic activities of paclitaxel are targeted to the activated tumor endothelial cells. Trial design •Patients with measurable locally advanced and/or metastatic adenocarcinoma of the pancreas failed on FOLFIRINOX treatment will be screened and randomized into one of the two arms in the study (n = 218). •ArmA: EndoTAG-1 and Gemcitabine Patients will be administrated with EndoTAG-1 (22 mg/m²) twice weekly plus gemcitabine (1000 mg/m²) once weekly for 1 cycle (8 weeks), which consisting of 3 weeks of treatment and 1 week rest, followed by 3 weeks of treatment and 1 week rest. The treatment will be kept until any one of the following occurs: progressive disease or unacceptable toxicity or withdrawal of consent. •ArmB: Gemcitabine Patients will be administrated with Gemcitabine (1000 mg/m²) once weekly for 1 cycle (8 weeks), which consisting of 3 weeks of treatment and 1 week rest, followed by 3 weeks of treatment and 1 week rest. The treatment will be kept until any one of the following occurs: progressive disease or unacceptable toxicity or withdrawal of consent. Clinical trial identification NCT03126435, other study ID numbers:CT4006. Legal entity responsible for the study SynCore Biotechnology Co., Ltd. Funding SynCore Biotechnology Co., Ltd. Disclosure All authors have declared no conflicts of interest.