Neoantigen vaccine combined with anti-PD1 and chemotherapy for pancreatic cancer treatment

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

This study is testing a new vaccine combined with anti-PD1 therapy and chemotherapy to see if it helps prevent pancreatic cancer from coming back after surgery.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 43 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Sichuan University (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy, radiation
• Locations: 1 site (Chengdu, Sichuan)
• Trial ID: NCT06344156 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the safety and efficacy of a neoantigen vaccine combined with anti-PD1 therapy and chemotherapy as an adjuvant treatment for patients who have undergone surgery for pancreatic cancer. It is a single-center, single-arm, prospective study focusing on patients with histologically confirmed pancreatic ductal adenocarcinoma who have had R0 resection and are in stages I-III. The study aims to evaluate how well this combination therapy works in preventing cancer recurrence after surgery.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with stage I-III pancreatic ductal adenocarcinoma who have undergone R0 resection and have not received prior neoadjuvant therapy.

Not a fit: Patients with a history of other malignancies or those who have received recent antitumor therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve survival rates and reduce the risk of recurrence in patients with pancreatic cancer.

How similar studies have performed: While the combination of neoantigen vaccines and immunotherapy is a novel approach, similar strategies in other cancers have shown promising results, indicating potential for success.

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.

Where this trial is running

Chengdu, Sichuan

• West China Hospital, Sichuan University — Chengdu, Sichuan, China (Recruiting)

Study contacts

• Principal investigator: zhong Wu, MD — West China Hospital
• Study coordinator: zhong Wu, MD

Conditions Pancreatic Cancer; Adjuvant Therapy; Neoantigen; Adjuvant therapy; Safety; Clinical efficacy