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
1988 - Molecular profiling reveals novel targetable biomarkers in neuroendocrine carcinoma of the uterine cervix
Presenter: Semir Vranic
Session: Poster Display session 2
Resources:
Abstract
2672 - Changes in clinico-pathological characteristics of vulvar cancer in Japan: increasing oldest-old, stage-shifting, and decreasing cohort-level survival
Presenter: Shin Nishio
Session: Poster Display session 2
Resources:
Abstract
4306 - Tumor Treating Fields (200 kHz) concomitant with weekly paclitaxel for platinum-resistant ovarian cancer: Phase 3 INNOVATE-3/ENGOT-ov50 study
Presenter: Ignace Vergote
Session: Poster Display session 2
Resources:
Abstract
5136 - Randomized, phase 1b/2 study of M6620 + avelumab + carboplatin vs standard care (sc) in patients (pts) with platinum-sensitive poly (ADP-ribose) polymerase inhibitor-(PARPi)-resistant ovarian cancer
Presenter: Susana Banerjee
Session: Poster Display session 2
Resources:
Abstract
2296 - An umbrella study of biomarker-driven targeted therapy in patients with platinum-resistant recurrent ovarian cancer: A Korean Gynecologic Oncology Group study (KGOG 3045), AMBITION
Presenter: Jung-Yun Lee
Session: Poster Display session 2
Resources:
Abstract
2732 - A phase 2 study of pembrolizumab in combination with doxorubicin in advanced, recurrent or metastatic endometrial cancer
Presenter: Ana Oaknin
Session: Poster Display session 2
Resources:
Abstract
4404 - ENGOT-EN9/LEAP-001: a phase 3, randomized, open-label study of pembrolizumab plus lenvatinib versus chemotherapy for first-line treatment of advanced or recurrent endometrial cancer
Presenter: Christian Marth
Session: Poster Display session 2
Resources:
Abstract
4564 - Phase 1/2 trial of tisotumab vedotin plus bevacizumab, pembrolizumab, or carboplatin in recurrent or metastatic cervical cancer (innovaTV 205/ENGOT-cx8)
Presenter: Ignace Vergote
Session: Poster Display session 2
Resources:
Abstract
4933 - Updated data of Epitopes-HPV02 trial and external validation of efficacy of DCF in prospective Epitopes-HPV01 study in advanced anal squamous cell carcinoma. Pooled analysis of 115 patients
Presenter: Stefano Kim
Session: Poster Display session 2
Resources:
Abstract
2301 - Pre-specified pilot analysis of a randomised pilot/phase II/III trial comparing standard dose vs dose-escalated concurrent chemoradiotherapy (CRT) in anal cancer (PLATO-ACT5)
Presenter: Alexandra Gilbert
Session: Poster Display session 2
Resources:
Abstract