Pancreas Cancer, Pancreas Cancer, Duct Cell Adenocarcinoma
Conditions
Keywords
adjuvant, pancreas cancer, mRNA
Brief summary
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
Detailed description
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
Interventions
BIOLOGICALAK154
AK154 is neotigeon personalized mRNA vaccine
BIOLOGICALCadonilimab
a PD-1/CTLA-4 bispecific antibody
BIOLOGICALIvonescimab (SMT112 or AK112) Injection
a PD-1/VEGF bi-specific antibody
DRUGmFOLFORINOX
mFOLFIRINOX:Fluorouracil+leucovorin+Irinotecan+Oxaliplatin
Sponsors
Fudan University
Akeso
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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 4 weeks prior to the first dose * Requiring systemic therapy with glucocorticoids or other immunosuppressive drugs within 14 days prior to initial administration. * Acute pancreatitis or subclinical pancreatitis * Active autoimmune disease * Allergic to immunotherapies and related drugs * History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation. * Splenectomy history * Active tuberculosis * Known or highly suspected history of interstitial pneumonia. * Clinically significant liver disease * Uncontrolled or severe cardiovascular disease. * Severe bleeding tendency or history of coagulopathy * Active malignancy within the last 3 years * Active syphilis infection * Any other situations that are not suitable for inclusion in this study judged by investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| DLT | Day 1 to Day 21 after the first tumour vaccine was administrated | Percentage of subjects who meet the criteria of DLT in DLT observation period |
| AE | From ICF up to 30days after last study treatment | Percentage of subjects with Adverse Events (AEs) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| RFS | 2 years | Recurrence free survival（RFS） |
| OS | 2 years | Overall survival（OS） |
Countries
China
Contacts
Primary ContactTing Liu
Outcome results
None listed