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NCT06156267 | NOT YET RECRUITING | Pancreatic Cancer

Study of Personalized Tumour Vaccines and a PD-L1 Blocker in Patients With Surgically Resected Pancreatic Adenocarcino
Sponsor:

Fudan University

Information provided by (Responsible Party):

X Ian-Jun Y U

Brief Summary:

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.

Condition or disease

Pancreatic Cancer

Intervention/treatment

Adebrelimab

mRNA tumor vaccines

Phase

EARLY_PHASE1

Study Type : INTERVENTIONAL
Estimated Enrollment : 30 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : An Exploratory Study of Neoantigen Personalized mRNA Vaccines in Combination With Adebrelimab and Sequential mFOLFIRINOX Regimen in Patients With Surgically Resected Pancreatic Adenocarcinoma
Actual Study Start Date : 2024-01
Estimated Primary Completion Date : 2026-04
Estimated Study Completion Date : 2027-03

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 75 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • 1. Voluntarily signed the informed consent form and complied with protocols requirements.
  • 2. Patients with radiographically resectable primary pancreatic tumors with histopathology or cytology confirmed resected ductal pancreatic adenocarcinoma (PDAC) with macroscopic complete resection (R0 and R1).
  • 3. Pancreatic cancer surgical staging per AJCC 8th edition staging: T 1-3, N0-2, M0.
  • 4. Tumour specimen availability.
  • 5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
  • 6. Life expectancy ≥ 6 months.
  • 7. Surgical complications have recovered, or complications lower than Clavien-Dindo complication grade 3.
  • 8. Adequate marrow and organ function.
  • 9. Patients with fertility are willing to use an adequate method of contraception.
Exclusion Criteria
  • 1. Prior anti-PDAC therapy (e.g., chemotherapy, radiotherapy, targeted therapy, immunotherapy and therapeutic tumor vaccines) prior to initiation of study treatment.
  • 2. Unsuitable for immunotherapy assessed by the investigator.
  • 3. 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.
  • 4. Have any active autoimmune disease, or have a history of autoimmune disease and have received systemic therapy in the past 2 years.
  • 5. Active tuberculosis or a history of active tuberculosis infection within 28 days prior to initiation of study treatment.
  • 6. Known or highly suspected history of interstitial pneumonia.
  • 7. Allergic to research drug ingredients, or have a history of severe allergic reactions to other vaccines.
  • 8. Prior malignancy within 5 years prior to study entry.
  • 9. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
  • 10. Known splenectomy history.
  • 11. Concurrent severe infection within 28 days prior to initiation of study treatment.
  • 12. Congenital or acquired immune deficiency.
  • 13. Active hepatitis B (HBV-DNA≥1000IU/ml), hepatitis C (hepatitis C antibody positive, and HCV-RNA higher than the lower limit of assay).
  • 14. Uncontrolled or severe cardiovascular disease.
  • 15. Other situations that are not suitable for inclusion in this study judged by investigator.
Study of Personalized Tumour Vaccines and a PD-L1 Blocker in Patients With Surgically Resected Pancreatic Adenocarcino

Location Details

NCT06156267

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How to Participate

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Locations

Not yet recruiting

China, Shanghai

Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University

Shanghai, Shanghai, China, 200032