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New treatment option for Pancreatic Cancer
Official title Neoantigen Vaccine Plus Anti-PD1 and Chemotherapy as an Adjuvant Therapy for Pancreatic Cancer
ClinicalTrials.gov ID: NCT06344156
What this study is testing
What is Neoantigen Vaccine Plus Anti-PD1 and Chemotherapy?
Neoantigen Vaccine Plus Anti-PD1 and Chemotherapy is an investigational medicine, being studied as a potential treatment for pancreatic cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Age ≥18 years and age ≤75 years.
- ECOG score 0-1.
- Patients with histologically confirmed pancreatic ductal adenocarcinoma, R0 resection, stage I-III, not receiving neoadjuvant therapy.
- Adequate bone marrow and organ function:
- Patients of childbearing potential must take appropriate precautions prior to enrollment and during the study.
You likely can't join if
- Received antitumor chemotherapy, radiation therapy, or immunotherapy within 2 weeks prior to first vaccination.
- 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...
- Uncontrollable comorbidities, including but not limited to active bacterial or fungal infections, symptomatic congestive heart failure, unstable...
- HIV infection or active hepatitis B (HBV DNA≥500IU/ml), hepatitis C.
- Uncontrolled coronary artery disease or asthma, uncontrolled cerebrovascular disease, or other conditions deemed ineligible by the investigator.
- Uncontrollable comorbidities, including but not limited to active bacterial or fungal infections, congestive heart failure, unstable angina...
See the full eligibility criteria
- Age ≥18 years and age ≤75 years.
- ECOG score 0-1.
- Patients with histologically confirmed pancreatic ductal adenocarcinoma, R0 resection, stage I-III, not receiving neoadjuvant therapy.
- Adequate bone marrow and organ function:
- Patients of childbearing potential must take appropriate precautions prior to enrollment and during the study.
- Signed informed consent.
- Ability to comply with the study protocol and follow-up.
- Received antitumor chemotherapy, radiation therapy, or immunotherapy within 2 weeks prior to first vaccination.
- 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...
- Uncontrollable comorbidities, including but not limited to active bacterial or fungal infections, symptomatic congestive heart failure, unstable angina, arrhythmias.
- HIV infection or active hepatitis B (HBV DNA≥500IU/ml), hepatitis C.
- Uncontrolled coronary artery disease or asthma, uncontrolled cerebrovascular disease, or other conditions deemed ineligible by the investigator.
- Uncontrollable comorbidities, including but not limited to active bacterial or fungal infections, congestive heart failure, unstable angina, arrhythmias, etc;
- Patients with autoimmune diseases or immunodeficiencies being treated with immunosuppressive drugs.
- Pregnant or lactating women.
- 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.
- Those who have had a severe allergic reaction to vaccines for other infectious diseases in the past.
- Those who may be allergic to the investigational product or any of its excipients.
- Substance abuse or inability to undergo immunotherapy due to clinical, psychological, or social factors.
- Significant weight loss (≥10%) within 6 weeks prior to enrollment.
- Any uncertain factors that may affect patient safety or compliance.
The study team makes the final eligibility decision.
Where it's taking place
- Chengdu, Sichuan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chengdu, Sichuan, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.