Intratumoral Influenza Vaccine for Early Colorectal Cancer
Ontology highlight
ABSTRACT:
DISEASE(S): Colorectal Cancer,Colorectal Neoplasms
PROVIDER: 2354826 | ecrin-mdr-crc |
REPOSITORIES: ECRIN MDR
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Primary endpoints: Safety endpointsSafety evaluation will be performed via continuous assessment of safety parameters by reviewing events as they arise. We will conduct the pilot study in order to measure potential safety issues in a small cohort of patients before including patients in the phase 2 study.The investigation will be put on hold if unacceptable safety issues are detected.Primary safety endpoints:1. Evaluation of serious adverse events2. Evaluation of any adverse events reported.
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Project description:Primary objectives: The aim of this randomized trial, is to establish thesafety and efficacy of electrochemotherapy in patients with colorectalcancer, as an additive treatment prior to intended curative surgery. Theelectroporation regime in this trial will be delivered through andendoscopic device, EndoVE. The CliniporatorTM will be used for pulsegeneration
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