Clinical trial · Interventional
Personalized Tumor Neoantigen MRNA Therapy Adjuvant Treatment for Postoperative Pancreatic Cancer.
Clinical Study to Evaluate the Safety and Efficacy of Personalized Tumor Neoantigen MRNA Therapy Combined with PD-1 Antibody and Chemotherapy As Adjuvant Treatment for Postoperative Pancreatic Cancer.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is a single-center, open-label clinical study to evaluate the feasibility and safety of personalized tumor neoantigen mRNA therapy (iNeo-Vac-R01) in combination with PD-1 antibody and standard chemotherapy regimen as adjuvant treatment for postoperative resectable pancreatic cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cancer Resectable | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gemcitabine + Capecitabine | Drug | — | UNRESOLVED |
| individualized anti-tumor new antigen iNeo-Vac-R01 injection | Biological | — | UNRESOLVED |
| Sintilimab injection | Drug | Sintilimab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A (Chemotherapy-Tolerant Patients)
- description
- Postoperative evaluation will be conducted within 4-12 weeks after surgery, and patients without recurrence will be enrolled. For patients who are chemotherapy-tolerant (evaluated by investigators), adjuvant therapy is to commence within 6-12 weeks postoperatively, with the first day of treatment (D1) defined as the date of initial postoperative intervention. Postoperative treatment follows the: 1.Gemcitabine + Capecitabine (GC) regimen+ Sintilimab: Gemcitabine: 1000 mg/m², intravenously on D1 and D8;Capecitabine: 1650-2000 mg/(m²·day), divided into two daily oral doses from D1 to D14;Sintilimab (200 mg); Q3W for 8 cycles.2.Personalized mRNA injection (100 μg subcutaneously, Q3W) administered from D22±3. On Day 43 ±3 days: The second efficacy assessment will be performed. Patients without disease progression will continue treatment. Patients with disease progression will transition to a second-line chemotherapy regimen (decided by investigators) combined with mRNA and Sintilimab.
- interventionNames
- Biological: individualized anti-tumor new antigen iNeo-Vac-R01 injection
- Drug: Gemcitabine + Capecitabine
- Drug: Sintilimab injection
- type
- EXPERIMENTAL
- label
- Arm B (Chemotherapy-Intolerant or Chemotherapy-Declined Patients)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Pre-Screening Phase Inclusion Criteria (for Radical Surgery and Vaccine Preparation): * Subjects meeting all of the following criteria will enter the pre-screening phase for radical surgery and vaccine preparation: * Voluntarily sign the informed consent form (ICF); * Age ≥18 years, regardless of gender; * Diagnosed with resectable pancreatic cancer as assessed per the 2024 NCCN Clinical Practice Guidelines and willing to undergo radical surgery; * ECOG Performance Status score of 0 or 1; * Ability to obtain sufficient fresh tumor tissue samples for whole-exome sequencing (WES) and transcriptome sequencing analysis; * Normal function of major organs (heart, liver, kidneys): * Liver function: Total bilirubin ≤1.5×ULN; ALT/AST ≤2.5×ULN; * Renal function: Serum creatinine ≤1.5×ULN or creatinine clearance ≥60 mL/min (Cockcroft-Gault formula); * Cardiac function: LVEF ≥50% by echocardiography; * Contraception agreement: Fertile males and females of childbearing potential must agree to use effective contraception from signing the ICF until 6 months after the last dose of study treatment. Females of childbearing potential include premenopausal women and women ≤2 years postmenopausal; * Ability to comply with the study protocol and follow-up procedures. 2. Formal Screening Phase Inclusion Criteria (for Study Treatment Initiation): * Subjects meeting all of the following criteria will enter the formal screening phase for study treatment: * Voluntarily sign the informed consent form (ICF); * Age ≥18 years, regardless of gender; * Histologically confirmed pancreatic ductal adenocarcinoma (PDAC) post-surgery; * Completion of radical resection (R0 or R1) with no evidence of metastatic disease, malignant ascites, or pleural effusion on imaging 4-12 weeks postoperatively; * ECOG Performance Status score:Cohort A: 0 or 1;Cohort B: 0-2; * Normal function of major organs (heart, liver, kidneys): * Contraception agreement: Same as pre-screening criteria; * Ability to comply with the study protocol and follow-up procedures. Exclusion Criteria: Subjects meeting any of the following criteria will be excluded from the study: * Serum CA 19-9 level \>180 U/mL within 21 days prior to initiating standard postoperative adjuvant therapy; * History of bone marrow transplantation, allogeneic organ transplantation, or allogeneic hematopoietic stem cell transplantation; * Concurrent immunosuppressive therapy, defined as regular use of immunosuppressive agents within 4 weeks prior to screening or during the study, including but not limited to: 1. Severe asthma requiring systemic corticosteroids (≥10 mg/day prednisone equivalent); 2. Active autoimmune disease or immunodeficiency (e.g., rheumatoid arthritis, systemic lupus erythematosus); 3. History of primary immunodeficiency; 4. Exceptions: Type 1 diabetes, autoimmune hypothyroidism managed with hormone replacement, vitiligo, or psoriasis not requiring systemic therapy; * Active bacterial/fungal infections requiring systemic treatment, or active/latent tuberculosis (confirmed by interferon-gamma release assay or tuberculin skin test); * Active viral infections: 1. HIV antibody-positive; 2. Syphilis (TP antibody-positive with RPR/TRUST confirmation); 3. Active hepatitis C (HCV RNA-positive); 4. Active hepatitis B (HBsAg-positive and HBV DNA ≥2000 IU/mL); * Acute viral infections: 1. Herpesvirus infection (unless resolved with crusting \>4 weeks prior); 2. Respiratory viral infection (unless resolved \>4 weeks prior); * Uncontrolled comorbidities: 1. Symptomatic congestive heart failure (NYHA Class III/IV); 2. Unstable angina or arrhythmia requiring treatment; 3. Severe coronary/cerebrovascular disease (e.g., myocardial infarction within 6 months); 4. Other conditions deemed exclusionary by the investigator; * History of drug abuse, psychiatric disorders, or psychosocial factors impairing informed consent or protocol compliance; * History of severe hypersensitivity to vaccines, biologics, or any component of the study drug; * Pregnancy or lactation; * Other conditions judged by the investigator to preclude safe participation.
References
Publications (0)
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