A Study of mRNA Vaccines AK154 Monotherapy or in Combination With AK104/AK112,and Sequential mFOLFIRINOX in Surgically Resected PDAC
An Exploratory Study to Evaluate Safety and Efficacy of the Neoantigen Personalized mRNA Vaccine AK154 Monotherapy or in Combination With AK104 or AK112,and the Sequential mFOLFIRINOX Regimen as Adjuvant Therapy in Surgically Resectable Pancreatic Ductal Adenocarcinoma
Sponsor: Akeso + Fudan University
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
DLT
Time frame: Day 1 to Day 21 after the first tumour vaccine was administrated
AE
Time frame: From ICF up to 30days after last study treatment
Secondary Endpoints
RFS
OS
Eligibility Criteria
Inclusion Criteria: * Voluntarily signed the informed consent form and complied with protocols requirements * Patients with radiographically resectable primary pancreatic tumors * Histopathology or cytology confirmed resected PDAC with macroscopic complete resection (R0 and R1) * Pancreatic cancer surgical staging per AJCC 8th edition staging: T 1-3, N0-2, M0 * ECOG 0 or 1 * Life expectancy ≥ 6 months * Surgical complications have recovered, * Adequate organ function * Patients with fertility are willing to use an adequate method of contraception. Exclusion Criteria: * The presence of other pathologic types * Participating in another clinical study * Have received treatment for pancreatic cancer, including chemotherapy, radiation therapy, targeted therapy, immunotherapy,etc * Plan to receive a live-attenuated vaccine within 28 days prior to initiation of study treatment or during the study treatment or within 90 days after the end of study treatment * Severe infection occurs within …
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