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About
A new approach that aims to destroy pancreatic tumor cells through modification of the tumor environment.
Asparagine synthetase (ASNS) is an enzyme wich synthetise asparagine. Asparagine is an essential nutriment for pancreatic cancer cells which have no or low level of ASNS.
by L-asparaginase encapsulated in erythrocytes deplete (supress) Plasma asparagine.
in selected patients having no or low ASNS, may provide a new therapeutic approach.
Enrollment
Sex
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Volunteers
Inclusion criteria
A patient is eligible for the study if all of the following criteria are met:
Exclusion criteria
A patient is excluded from the study if any of the following criteria are met:
Patient who have received Oxaliplatin in first line will not be eligible in FOLFOX arm; Patient who received Gemcitabine in first line will not be eligible in Gemcitabine arm
Resectable pancreatic adenocarcinoma
Known hypersensitivity to L-asparaginase or have had prior exposure to any form of L-asparaginase
Anti-vitamin K treatment. Replacement with low molecular weight heparin treatment if required
Inadequate organ functions:
hemoglobin < 9.0 g/dl, neutrophil count < 1.5 x 109/L, platelets < 100 x 109/L.
Liver or pancreatic function abnormalities
Renal insufficiency: Renal clearance determined by the Cockroft and Gault Formula < 60 mL/min
Current or prior coagulopathy disorders in the last month
Known Infection: HIV, active hepatitis related to B or C virus
Concurrent active malignancies (with the exception of in situ carcinoma of the cervix and inactive non melanoma skin cancer
Other serious conditions than pancreatic cancer according to investigator's opinion
NYHA Grade ≥ 2 congestive heart failure
Systemic chemotherapy or radiation within the last 3 weeks or major surgery within 4 weeks NOTE: chemotherapy or radiation therapy given in less than 3 weeks is allowed, provided patient recovered from all related toxicities
History of grade 3 blood transfusion reaction (life threatening situation)
Presence of anti-erythrocyte antibodies (auto-antibodies or anti-public antibodies) preventing from getting a compatible packed Red Blood Cells for the patient
Participation in another concurrent clinical trial
Women of child-bearing potential and men with partners of childbearing potential without effective contraception as well as pregnant or breast feeding women
Other severe acute/chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the Investigator would make the patient inappropriate for entry into this study.
Primary purpose
Allocation
Interventional model
Masking
141 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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