NCT06913218Not yet recruitingPhase 1
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
Source: ClinicalTrials.gov · Last updated 6 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 30 Mar 2025
- Start date
- 22 Jul 2025
- Primary completion date
- 23 Feb 2028
- Lead sponsor
- Akeso
- Diseases
- Pancreatic cancer
- NCT number
- NCT06913218
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 60
- From 22 Jul 2025 to the primary completion date, 23 Feb 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Active autoimmune disease
- Allergic to immunotherapies and related drugs
- History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
- 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
Other
- The presence of other pathologic types
- Participating in another clinical study
- Acute pancreatitis or subclinical pancreatitis
- Splenectomy history
- Any other situations that are not suitable for inclusion in this study judged by investigator.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Pancreatic Surgery,Fudan University Shanghai Cancer Center Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.