A Study of mRNA Vaccines AK154 Monotherapy or in Combination With AK104/AK112,and Sequential mFOLFIRINOX in Surgically Resected PDAC
NCT ID: NCT06913218
Last Updated: 2025-04-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
PHASE1
60 participants
INTERVENTIONAL
2025-07-22
2028-11-06
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study of Personalized Tumour Vaccines and a PD-L1 Blocker in Patients With Surgically Resected Pancreatic Adenocarcino
NCT06156267
Safety and Efficacy Study of Mix Vaccine in Pancreatic Carcinoma Patient
NCT02338752
Ivonescimab(AK112/SMT112) in Combination With Stereotactic Body Radiation Therapy and Chemotherapy in Patients With Pancreatic Cancer
NCT06491472
Newly Emerging Immunotherapy for Pancreatic Cancer Treatment
NCT06370754
A Study of AK130 in Combination With AK112 for the Treatment of Advanced Pancreatic Cancer
NCT07114315
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SEQUENTIAL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Pancreatic Cancer
Resectable PDAC
AK154
AK154 is neotigeon personalized mRNA vaccine
Cadonilimab
a PD-1/CTLA-4 bispecific antibody
Ivonescimab (SMT112 or AK112) Injection
a PD-1/VEGF bi-specific antibody
mFOLFORINOX
mFOLFIRINOX:Fluorouracil+leucovorin+Irinotecan+Oxaliplatin
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
AK154
AK154 is neotigeon personalized mRNA vaccine
Cadonilimab
a PD-1/CTLA-4 bispecific antibody
Ivonescimab (SMT112 or AK112) Injection
a PD-1/VEGF bi-specific antibody
mFOLFORINOX
mFOLFIRINOX:Fluorouracil+leucovorin+Irinotecan+Oxaliplatin
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Fudan University
OTHER
Akeso
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Department of Pancreatic Surgery,Fudan University Shanghai Cancer Center
Shanghai, Xuhui, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
AK154-IIT-001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.