To explore safety and efficacy of neoantigen personalized mRNA vaccines AK154 monotherapy or in combination with AK104/AK112 and sequential mFOLFIRINOX regime in Resected PDAC
This is a prospective, open-label, single-center, exploratory clinical study. To explore the safety, tolerability, efficacy, immunogenicity, and PK/PD profile of neoantigen personalized mRNA vaccine AK154 monotherapy or combined with AK104 or AK112, sequential mFOLFIRINOX chemotherapy regimen as postoperative adjuvant therapy in Surgically Resected Pancreatic Adenocarcino
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
AK154 is neotigeon personalized mRNA vaccine
a PD-1/CTLA-4 bispecific antibody
a PD-1/VEGF bi-specific antibody
Department of Pancreatic Surgery,Fudan University Shanghai Cancer Center
Shanghai, Xuhui, China
DLT
Percentage of subjects who meet the criteria of DLT in DLT observation period
Time frame: Day 1 to Day 21 after the first tumour vaccine was administrated
AE
Percentage of subjects with Adverse Events (AEs)
Time frame: From ICF up to 30days after last study treatment
RFS
Recurrence free survival(RFS)
Time frame: 2 years
OS
Overall survival(OS)
Time frame: 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
mFOLFIRINOX:Fluorouracil+leucovorin+Irinotecan+Oxaliplatin