Actively Recruiting
Adjuvant Therapy of Neoantigen Vaccine Plus Anti-PD1 and Chemotherapy in Patients With Resected Pancreatic Cancer
Led by Sichuan University · Updated on 2025-02-28
43
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of a combination treatment using a neoantigen vaccine, anti-PD1 therapy, and chemotherapy as additional (adjuvant) therapy after surgery for pancreatic cancer. This phase 1, single center, and single arm study aims to explore these treatments in patients who have had pancreatic ductal adenocarcinoma removed and want to prevent cancer recurrence. The study is sponsored by Sichuan University and focuses on patients aged 18 to 75 years with specific health criteria. Participants will receive 8 cycles of chemotherapy with gemcitabine and capecitabine, plus two intravenous doses of the anti-PD1 drug tislelizumab every three weeks. Alongside this, they will get five priming doses of the neoantigen vaccine at specific intervals (days 1, 8, 22, 36, and 50) and two booster doses later (days 80 and 110). This treatment plan is designed to be given after surgery to help reduce the chance of cancer returning. Throughout the study, participants will be closely monitored with safety checks and follow-ups. Researchers will measure how long patients remain free from cancer recurrence up to 18 months and will track any treatment-related side effects for three months after the last vaccine dose. The study will also look at overall survival up to 18 months or longer. Patients will undergo regular evaluations, including clinical assessments and laboratory tests, over an average period of about two years.
CONDITIONS
Brief Title
Neoantigen Vaccine Plus Anti-PD1 and Chemotherapy as an Adjuvant Therapy for Pancreatic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years and older, up to 75 years
- ECOG performance status score of 0 or 1
- Histologically confirmed pancreatic ductal adenocarcinoma with complete (R0) resection, stage I-III
- No neoadjuvant therapy received prior to surgery
- Adequate bone marrow and organ function
- Patients able to take precautions if of childbearing potential
- Signed informed consent
- Ability to follow study protocol and attend follow-up visits
You will not qualify if you...
- Received chemotherapy, radiation, or immunotherapy within 2 weeks before first vaccination
- History of other tumors except certain treated cancers or those treated with curative intent over 5 years ago
- Uncontrollable comorbid conditions such as active infections, congestive heart failure, unstable angina, or arrhythmias
- HIV infection or active hepatitis B or C
- Uncontrolled coronary artery disease, asthma, cerebrovascular disease, or other conditions deemed ineligible
- Autoimmune diseases or immunodeficiencies treated with immunosuppressive drugs
- Pregnant or breastfeeding women
- Vaccination with other preventive vaccines within 4 weeks before or planned during the study
- Severe past allergic reactions to vaccines
- Allergy to study product or its ingredients
- Substance abuse or inability to undergo immunotherapy due to clinical, psychological, or social reasons
- Significant weight loss (10% or more) within 6 weeks before enrollment
- Any other factors that may affect safety or compliance with the study protocol
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Approximately 16 weeks
Participants receive 8 cycles of chemotherapy with Gemcitabine and Capecitabine, two doses of tislelizumab, and multiple doses of neoantigen vaccines as part of the adjuvant therapy.
Multiple visits corresponding to chemotherapy cycles and vaccine doses over the treatment period
Trial Site Locations
Total: 1 location
1
West China Hospital, Sichuan University
Chengdu, Sichuan, China, 610000
Actively Recruiting
Research Team
Z
zhong Wu, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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