Clinical trial NCT06344156: Neoantigen Vaccine Plus Anti-PD1 and Chemotherapy as an Adjuvant Therapy for Pancreatic Cancer
Official title: Adjuvant Therapy of Neoantigen Vaccine Plus Anti-PD1 and Chemotherapy in Patients With Resected Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Pancreatic Cancer
Adjuvant Therapy
Keywords: Pancreatic Cancer
Neoantigen
Adjuvant therapy
Safety
Clinical efficacy
Lead sponsor: Sichuan University
Sponsor class: OTHER
First posted: 2024-04-03
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this single center, single arm and prospective study is to explore the safety and efficacy of Neoantigen Vaccine Plus Anti-PD1 and Chemotherapy in postoperative adjuvant treatment of Pancreatic Cancer


Eligibility criteria: Inclusion Criteria:

1. Age ≥18 years and age ≤75 years.
2. ECOG score 0-1.
3. Patients with histologically confirmed pancreatic ductal adenocarcinoma, R0 resection, stage I-III, not receiving neoadjuvant therapy.
4. Adequate bone marrow and organ function:
5. Patients of childbearing potential must take appropriate precautions prior to enrollment and during the study.
6. Signed informed consent.
7. Ability to comply with the study protocol and follow-up.

Exclusion Criteria:

1. Received antitumor chemotherapy, radiation therapy, or immunotherapy within 2 weeks prior to first vaccination.
2. The patient has a history of other tumors, except for cervical cancer in situ, treated squamous cell carcinoma or urothelial tumors (Ta and TIS), or other malignancies that have been treated with curative intent (at least 5 years prior to enrollment).
3. Uncontrollable comorbidities, including but not limited to active bacterial or fungal infections, symptomatic congestive heart failure, unstable angina, arrhythmias.
4. HIV infection or active hepatitis B (HBV DNA≥500IU/ml), hepatitis C.
5. Uncontrolled coronary artery disease or asthma, uncontrolled cerebrovascular disease, or other conditions deemed ineligible by the investigator.
6. Uncontrollable comorbidities, including but not limited to active bacterial or fungal infections, congestive heart failure, unstable angina, arrhythmias, etc;
7. Patients with autoimmune diseases or immunodeficiencies being treated with immunosuppressive drugs.
8. Pregnant or lactating women.
9. Vaccination with other preventive vaccines within 4 weeks before the first administration or planned during the study period, including within 8 weeks after the last vaccination.
10. Those who have had a severe allergic reaction to vaccines for other infectious diseases in the past.
11. Those who may be allergic to the investigational product or any of its excipients.
12. Substance abuse or inability to undergo immunotherapy due to clinical, psychological, or social factors.
13. Significant weight loss (≥10%) within 6 weeks prior to enrollment.
14. Any uncertain factors that may affect patient safety or compliance.

Primary outcomes:
measure: 18-month RFS
timeFrame: through study completion, an average of 2 year
measure: Incidence of Treatment-Related Adverse Events [Safety and Tolerability]
timeFrame: 3 months after the last administration of neoantigen vaccine
Secondary outcomes:
measure: 18-month OS
timeFrame: through study completion, an average of 3 year
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
state: Sichuan
Study officials:
affiliation: West China Hospital
name: zhong Wu, MD
role: PRINCIPAL_INVESTIGATOR
References: