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

Pancreatic Cancer Clinical Trial

Official title:

Adjuvant Therapy of Neoantigen Vaccine Plus Anti-PD1 and Chemotherapy in Patients With Resected Pancreatic Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06344156
• Other study ID #: PDAC-Neoantigen
• Status: Recruiting
• Phase: Phase 1
• Start date: April 1, 2024
• Est. completion date: April 1, 2027

Study information

• Verified date: March 2024
• Source: Sichuan University
• Contact: zhong Wu, MD
• Phone: 028-85422851
• Email: wuzhong5555[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 43
• Est. completion date: April 1, 2027
• Est. primary completion date: April 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adjuvant Therapy
• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• Neoantigen Vaccine Plus Anti-PD1 and Chemotherapy
Gemcitabine +capecitabine, tislelizumab, neoantigen vaccines

Locations

Country	Name	City	State
China	West China Hospital, Sichuan University	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Sichuan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	18-month RFS	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.	through study completion, an average of 2 year
Primary	Incidence of Treatment-Related Adverse Events [Safety and Tolerability]	Defined by treatment-related adverse events as assessed by CTCAE v4.0	3 months after the last administration of neoantigen vaccine
Secondary	18-month OS	defined OS from the date of surgery to the date of death.	through study completion, an average of 3 year