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

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

Neoantigen Vaccine Plus Anti-PD1 and Chemotherapy as an Adjuvant Therapy for Pancreatic Cancer (NCT06344156) is a Phase 1 interventional studying Pancreatic Cancer and Adjuvant Therapy, sponsored by Sichuan University. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Pancreatic Cancer, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 43 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Age ≥18 years and age ≤75 years. 2. ECOG score 0-1. 3. Patients with diagnosed by tissue sample (biopsy-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 willing to sign a consent form. 7. Ability to comply with the study protocol and follow-up. Who Should NOT Join This Trial: 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 conditions (where your immune system attacks your own body)s 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. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

DRUG

Neoantigen Vaccine Plus Anti-PD1 and Chemotherapy

Gemcitabine +capecitabine, tislelizumab, neoantigen vaccines

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

West China Hospital, Sichuan University

Chengdu, Sichuan, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06344156), the sponsor (Sichuan University), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06344156 clinical trial studying?

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 The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06344156?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06344156?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06344156. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06344156. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.