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Recruiting NCT06344156

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

Phase I Interventional Pancreatic Cancer Adjuvant Therapy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Neoantigen Vaccine Plus Anti-PD1 and Chemotherapy.
Who it may be relevant to
Registry conditions: Pancreatic Cancer, Adjuvant Therapy. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Interventions

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

Primary outcome measures

  • 18-month RFS [Time frame: through study completion, an average of 2 year]
  • Incidence of Treatment-Related Adverse Events [Safety and Tolerability] [Time frame: 3 months after the last administration of neoantigen vaccine]
Secondary outcome measures (1)
  • 18-month OS [Time frame: through study completion, an average of 3 year]

Eligibility criteria

Inclusion 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.

Exclusion criteria

  • 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 least 5 years prior to enrollment).
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • West China Hospital, Sichuan University — Chengdu

Identifiers

NCT: NCT06344156 · CHANT-231

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗