NCT06156267Not yet recruitingEarly phase 1
Study of Personalized Tumour Vaccines and a PD-L1 Blocker in Patients With Surgically Resected Pancreatic Adenocarcino
An Exploratory Study of Neoantigen Personalized mRNA Vaccines in Combination With Adebrelimab and Sequential mFOLFIRINOX Regimen in Patients With Surgically Resected Pancreatic Adenocarcinoma
Source: ClinicalTrials.gov · Last updated 5 Dec 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This is a phase 1, open-label study to evaluate the safety and tolerability of neoantigen personalized mRNA tumour vaccine combined with Adebrelimab (a PD-L1 humanized monoclonal antibody) in patients with surgically resected pancreatic adenocarcinoma.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 8 Nov 2023
- Start date
- Jan 2024
- Primary completion date
- Apr 2026
- Lead sponsor
- Fudan University
- Diseases
- Pancreatic cancer
- NCT number
- NCT06156267
What you commit to
- Study type: Interventional · Early phase 1
- Planned participants: 30
- From Jan 2024 to the primary completion date, Apr 2026
- 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
- Prior anti-PDAC therapy (e.g., chemotherapy, radiotherapy, targeted therapy, immunotherapy and therapeutic tumor vaccines) prior to initiation of study treatment.
- Unsuitable for immunotherapy assessed by the investigator.
- 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.
- Have any active autoimmune disease, or have a history of autoimmune disease and have received systemic therapy in the past 2 years.
- Active tuberculosis or a history of active tuberculosis infection within 28 days prior to initiation of study treatment.
- Concurrent severe infection within 28 days prior to initiation of study treatment.
Other illness
- Known or highly suspected history of interstitial pneumonia.
- Allergic to research drug ingredients, or have a history of severe allergic reactions to other vaccines.
- Prior malignancy within 5 years prior to study entry.
- Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
- Active hepatitis B (HBV-DNA≥1000IU/ml), hepatitis C (hepatitis C antibody positive, and HCV-RNA higher than the lower limit of assay).
- Uncontrolled or severe cardiovascular disease.
Other
- Known splenectomy history.
- Congenital or acquired immune deficiency.
- 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 with histopathology or cytology confirmed resected ductal pancreatic adenocarcinoma (PDAC) with macroscopic complete resection (R0 and R1).
- Pancreatic cancer surgical staging per AJCC 8th edition staging: T 1-3, N0-2, M0.
- Tumour specimen availability.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
- Life expectancy ≥ 6 months.
- Surgical complications have recovered, or complications lower than Clavien-Dindo complication grade 3.
- Adequate marrow and 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; Pancreatic Cancer Institute, Fudan University Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.