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

NCT ID: NCT06344156

Last Updated: 2025-02-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-01
• Study Completion Date: 2027-04-01

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

Conditions

Pancreatic Cancer; Adjuvant Therapy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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)

Group Type: EXPERIMENTAL

Neoantigen Vaccine Plus Anti-PD1 and Chemotherapy

Intervention Type: DRUG

Gemcitabine +capecitabine, tislelizumab, neoantigen vaccines

Interventions

Neoantigen Vaccine Plus Anti-PD1 and Chemotherapy

Gemcitabine +capecitabine, tislelizumab, neoantigen vaccines

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sichuan University

OTHER

Sponsor Role: lead

Responsible Party

Zhen-Yu Ding

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

zhong Wu, MD

Role: PRINCIPAL_INVESTIGATOR

West China Hospital

Locations

West China Hospital, Sichuan University

Chengdu, Sichuan, China

Site Status: RECRUITING

Countries

China

Central Contacts

zhong Wu, MD

Role: CONTACT

wuzhong5555@126.com

028-85422851

Facility Contacts

Zhong Wu, MD

Role: primary

wuzhong5555@126.com

028-85422851

Other Identifiers

CHANT-231

Identifier Type: -

Identifier Source: org_study_id