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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• West China Hospital, Sichuan University
  Chengdu, Sichuan, China Recruiting

Study contacts

• Principal investigator: zhong Wu, MD — West China Hospital
• Study coordinator: zhong Wu, MD
• Email: wuzhong5555@126.com
• Phone: 028-85422851

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Combining irinotecan liposome with oxaliplatin and tegafur for pancreatic cancer treatment

  This study tests if a new combination of chemotherapy drugs can help people who have had surgery for pancreatic cancer recover better and stay cancer-free longer.

  Recruiting The First Affiliated Hospital with Nanjing Medical University · Nanjing, Jiangsu · NCT06361316

• Integrated genomic and clinical database for cancer biomarker discovery

  Researchers are building a combined genomic and clinical database at Samsung Medical Center to test biomarkers for cancer diagnosis, treatment choice, and predicting how well treatments work.

  Recruiting Samsung Medical Center · Seoul, Gang-Nam · NCT07911267

• Using contrast-enhanced ultrasound to check for local pancreatic cancer recurrence after surgery

  This pilot test uses contrast-enhanced ultrasound to see if it can help detect return of pancreatic cancer after surgery in patients being watched with CT scans.

  Recruiting Thomas Jefferson University · Philadelphia, Pennsylvania · NCT07910383

• Combination of ivermectin with standard skin-protective care for daraxonrasib-related skin toxicity in pancreatic cancer

  This study tests whether adding ivermectin to standard preventive skin care helps people with pancreatic cancer who develop skin side effects from daraxonrasib.

  Recruiting at 7 sites Phase 2 Memorial Sloan Kettering Cancer Center · Basking Ridge, New Jersey and 6 other locations · NCT07895498

• Becotatug Vedotin Plus Anti-PD-1 and S-1 in EGFR-Positive Advanced Pancreatic Cancer

  This study tests a three-drug regimen (becotatug vedotin, an anti-PD-1 therapy, and S-1) in adults with EGFR-positive advanced pancreatic cancer who have not responded to at least one prior therapy.

  Recruiting Ningbo Medical Center Lihuili Hospital · Ningbo, Zhejiang · NCT07892573

• Blood protein biomarkers to help diagnose pancreatic cancer in adults

  This study tests whether blood protein biomarkers can help detect pancreatic ductal adenocarcinoma and tell it apart from chronic pancreatitis and mucinous pancreatic lesions, and whether combining markers with CA 19-9 improves accuracy.

  Recruiting Grigore T. Popa University of Medicine and Pharmacy · Iași · NCT07875582

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.