Abstract 5509
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.
Editorial acknowledgement
Legal entity responsible for the study
SynCore Biotechnology Co., Ltd.
Funding
SynCore Biotechnology Co., Ltd.
Disclosure
All authors have declared no conflicts of interest.
Resources from the same session
1902 - Phase II trial of preoperative modified FOLFIRINOX (mFOLFIRINOX) followed by postoperative gemcitabine (GEM) in patients (pts) with borderline resectable (BR) and locally advanced (LA) pancreatic ductal adenocarcinoma (PDAC)
Presenter: Jae Ho Jeong
Session: Poster Display session 2
Resources:
Abstract
3716 - Prognostic factors for predicting early recurrence within the first year of surgery in pancreatic ductal adenocarcinoma
Presenter: Naru Kim
Session: Poster Display session 2
Resources:
Abstract
3947 - Integrated population pharmacokinetic modelling of liposomal irinotecan in patients with various tumour types, including untreated metastatic pancreatic cancer (mPC)
Presenter: Teresa Macarulla
Session: Poster Display session 2
Resources:
Abstract
2880 - Expression of long noncoding RNA and clinical outcomes of pancreatic cancer patients who received adjuvant chemotherapy by S-1 or GEM after curative resection.
Presenter: Mariko Kamiya
Session: Poster Display session 2
Resources:
Abstract
5029 - POLO: Time to treatment discontinuation and subsequent therapies following maintenance olaparib for patients (pts) with a germline BRCA mutation and metastatic pancreatic cancer (mPC)
Presenter: Eric Van Cutsem
Session: Poster Display session 2
Resources:
Abstract
4730 - Diagnostic Value of Digital Multiplexed Detection of Single Nucleotide Variants in Pancreatic Cancer Specimens Collected by Endoscopic Ultrasound Fine-Needle Aspiration
Presenter: Irina Cazacu
Session: Poster Display session 2
Resources:
Abstract
3303 - Phase I/II study of LDE225 in combination with gemcitabine and nab-paclitaxel in patients with metastatic pancreatic cancer
Presenter: Esther Pijnappel
Session: Poster Display session 2
Resources:
Abstract
2009 - Efficacy of platinum-containing chemotherapy and prognosis of pancreatic cancer patients with homologous recombination deficiency: meta-analysis of published clinical studies
Presenter: Elizeveta Polyanskaya
Session: Poster Display session 2
Resources:
Abstract
2164 - Plasmatic CXCL8 is a marker for TGFß-activated kinase 1 (TAK1) activation which may predict resistance to nanoliposomal irinotecan (nal-IRI) in gemcitabine-refractory pancreatic cancer (PC) patients
Presenter: Valeria Merz
Session: Poster Display session 2
Resources:
Abstract
2529 - A protein level signature of four selected genes associated with survival outcomes of patients with pancreatic ductal adenocarcinoma
Presenter: Jie Hua
Session: Poster Display session 2
Resources:
Abstract