Neoantigen Vaccine Plus Anti-PD1 and Chemotherapy As an Adjuvant Therapy for Pancreatic Cancer

Phase 1

Recruiting

• Conditions: Adjuvant Therapy; Pancreatic Cancer
• Interventions: Drug: Neoantigen Vaccine Plus Anti-PD1 and Chemotherapy

• Registration Number: NCT06344156
• Lead Sponsor: Sichuan University

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-03-27
• Study First Submitted QC: 2024-03-27
• Study Start: 2024-04-01
• Study First Posted: 2024-04-03
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-25
• Last Update Posted: 2025-02-28
• Primary Completion: 2026-04-01
• Study Completion: 2027-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 43

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Neoantigen Vaccine Plus Anti-PD1 and Chemotherapy	Neoantigen Vaccine Plus Anti-PD1 and Chemotherapy	(1)8 cycles of Gemcitabine +capecitabine (Gemcitabine d1,8 ,Capecitabine d1-14 q3w）；（2） two 200 mg intravenous dose of tislelizumab (d1,q3w)（3）five intravenous doses of neoantigen vaccines given as priming doses(d1,8,22,36,50）and two booster dose(d80,d110)

Primary Outcome Measures

Name	Time	Method
Incidence of Treatment-Related Adverse Events [Safety and Tolerability]	3 months after the last administration of neoantigen vaccine	Defined by treatment-related adverse events as assessed by CTCAE v4.0
18-month RFS	through study completion, an average of 2 year	defined recurrence as new lesions on the basis of response evaluation criteria in solid tumours (v.1.1), and RFS from either the date of surgery (RFS) or from the date of the last neoantigen vaccine priming dose to the date of recurrence or death, whichever occurred first.

Secondary Outcome Measures

Name	Time	Method
18-month OS	through study completion, an average of 3 year	defined OS from the date of surgery to the date of death.

Trial Locations

Locations (1)

West China Hospital, Sichuan University; 🇨🇳 Chengdu, Sichuan, China