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

Sichuan University

Status and phase: Enrolling; Phase 1

Conditions: Adjuvant Therapy; Pancreatic Cancer

Treatments: Drug: Neoantigen Vaccine Plus Anti-PD1 and Chemotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06344156

CHANT-231

Details and patient eligibility

About

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

Enrollment: 43 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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43 participants in 1 patient group

Neoantigen Vaccine Plus Anti-PD1 and Chemotherapy

Experimental group

Description:

(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)

Treatment:

Drug: Neoantigen Vaccine Plus Anti-PD1 and Chemotherapy