Status:
NOT_YET_RECRUITING
Study of Personalized Tumour Vaccines and a PD-L1 Blocker in Patients With Surgically Resected Pancreatic Adenocarcino
Lead Sponsor:
Fudan University
Collaborating Sponsors:
Shanghai Regenelead Therapies Co., Ltd.
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18-75 years
Phase:
EARLY_PHASE1
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- 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.
- Known splenectomy history.
- Concurrent severe infection within 28 days prior to initiation of study treatment.
- Congenital or acquired immune deficiency.
- 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 situations that are not suitable for inclusion in this study judged by investigator.
Key Trial Info
Start Date :
January 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2027
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06156267
Start Date
January 1 2024
End Date
March 1 2027
Last Update
December 5 2023
Active Locations (1)
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1
Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University
Shanghai, Shanghai Municipality, China, 200032