Pancreatic Cancer ResectablePhase 1/2NCT06888674
Personalized Tumor Neoantigen MRNA Therapy Adjuvant Treatment for Postoperative Pancreatic Cancer.
A Phase 1/2 study testing individualized anti-tumor new antigen iNeo-Vac-R01 injection, Gemcitabine + Capecitabine and Sintilimab injection in people with Pancreatic Cancer Resectable, run by Zhejiang University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pancreatic Cancer Resectable
- What is being tested?
- individualized anti-tumor new antigen iNeo-Vac-R01 injection, Gemcitabine + Capecitabine and Sintilimab injection
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2025to 1 Apr 2029
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
- 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.
Who cannot join
- 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:
- Severe asthma requiring systemic corticosteroids (≥10 mg/day prednisone equivalent);
- Active autoimmune disease or immunodeficiency (e.g., rheumatoid arthritis, systemic lupus erythematosus);
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- History of primary immunodeficiency;
- 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:
- HIV antibody-positive;
- Syphilis (TP antibody-positive with RPR/TRUST confirmation);
- Active hepatitis C (HCV RNA-positive);
- Active hepatitis B (HBsAg-positive and HBV DNA ≥2000 IU/mL);
- Acute viral infections:
- Herpesvirus infection (unless resolved with crusting >4 weeks prior);
- Respiratory viral infection (unless resolved >4 weeks prior);
- Uncontrolled comorbidities:
- Symptomatic congestive heart failure (NYHA Class III/IV);
- Unstable angina or arrhythmia requiring treatment;
- Severe coronary/cerebrovascular disease (e.g., myocardial infarction within 6 months);
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
First Affiliated Hospital of Zhejiang University Schlool of Medicine
Hangzhou, Zhejiang
Yiwen Chen, MD., +8615088682641, yiwenchen0705@126.com
About this study
Official title: 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.
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
- Pancreatic Cancer Resectable
- Being tested
- individualized anti-tumor new antigen iNeo-Vac-R01 injection, Gemcitabine + Capecitabine, Sintilimab injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
individualized anti-tumor new antigen iNeo-Vac-R01 injectionBiological
The individualized anti-tumor new antigen iNeo-Vac-R01 injection was commissioned by Hangzhou Neoantigen Therapeutics Co., Ltd., and all patients were admitted into the therapeutic intervention group. According to the results of previous non-clinical studies, the individualized mRNA injection of 100 μ g was a tolerable dose.
Gemcitabine + CapecitabineDrug
Gemcitabine: 1000 mg/m², administered intravenously over 30 minutes on Day 1 and Day 8; Capecitabine: 1650-2000 mg/(m²·day), divided into two daily oral doses from Day 1 to Day 14.
Treatment cycles repeat every 3 weeks for 8 cycles, with the actual number of cycles determined by the investigator based on comprehensive evaluation of the patient's physical status, disease progression, and adverse reactions.
Sintilimab injectionDrug
Sintilimab Injection, 200mg, intravenous infusion, every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Arm A (Chemotherapy-Tolerant Patients) | Experimental | 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. Receives: Biological: individualized anti-tumor new antigen iNeo-Vac-R01 injection; Drug: Gemcitabine + Capecitabine; Drug: Sintilimab injection |
| Arm B (Chemotherapy-Intolerant or Chemotherapy-Declined Patients) | Experimental | Postoperative evaluation will be conducted within 4-12 weeks after surgery, and patients without recurrence will be enrolled. For patients who are Chemotherapy-Intolerant or Chemotherapy-Declined, postoperative treatment consists of Sintilimab (200 mg via intravenous infusion) administered Q3W for 8 cycles. On Day 22 ± 3 days, patients will initiate treatment with personalized mRNA injection at a dose of 100 μg administered subcutaneously Q3W, for a maximum of 9 doses.
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 personalized mRNA injection (100 μg subcutaneously,Q3W) and Sintilimab (200 mg via intravenous infusion, Q3W). Receives: Biological: individualized anti-tumor new antigen iNeo-Vac-R01 injection; Drug: Sintilimab injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurence and frequence of AE and SAE
Occurence and frequence of Adverse Event (AE) and Serious Adverse Event (SAE) (NCI CTCAE 5.0)
Measured: Up to 2 years
Secondary outcomes (10)
Recurrence-Free Survival (RFS)
Defined as the time from the date of surgery to the first occurrence of disease recurrence or death from any cause (whichever occurs first). Tumor recurrence is defined as the development of one or more new lesions, which may be local (at the primary site), regional (in adjacent lymph nodes or tissues), or distant (metastatic lesions remote from the original resection site).
Measured: Up to 2 years
Recurrence-Free Survival Rate (RFS%)
The proportion of patients free from disease recurrence or death (whichever occurs first) at 12 months, 24 months, and 36 months following surgery.
Measured: Up to 3 years
Overall Survival (OS)
Defined as the time from the date of surgery to death from any cause.
Measured: Up to 4 years
Overall Survival Rate (OS%)
The proportion of patients surviving at 12 months, 24 months, and 36 months following surgery.
Measured: Up to 3 years
Efficacy Evaluation Metrics for Patients with Recurrence: Objective Response Rate (ORR)
The proportion of patients achieving a partial response (PR) or complete response (CR) in tumor lesions, as defined by RECIST 1.1 criteria.
Measured: Up to 3 years
Efficacy Evaluation Metrics for Patients with Recurrence: Disease Control Rate (DCR)
The proportion of patients achieving PR, CR, or stable disease (SD) in tumor lesions.
Measured: Up to 3 years
Efficacy Evaluation Metrics for Patients with Recurrence: Progression-Free Survival (PFS)
Defined as the time from the date of initiating first-line chemotherapy to the first occurrence of disease progression or death from any cause (whichever occurs first).
Measured: Up to 3 years
Efficacy Evaluation Metrics for Patients with Recurrence: Progression-Free Survival Rate (PFS%)
The proportion of patients free from disease progression or death (whichever occurs first) at 12, 24, and 36 months.
Measured: Up to 3 years
Efficacy Evaluation Metrics for Patients with Recurrence: Overall Survival (OS)
Defined as the time from the date of initiating first-line chemotherapy to death from any cause.
Measured: Up to 4 years
Efficacy Evaluation Metrics for Patients with Recurrence: Overall Survival Rate (OS%)
The proportion of patients surviving at 12, 24, and 36 months.
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2025
- Study start1 Apr 2025 (estimated)
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Cancer ResectableStudies of the same condition, open and under way.
- More trials run by Zhejiang UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Collaborators
- Hangzhou Neoantigen Therapeutics Co., Ltd.
- Responsible party
- Principal investigator, TingBo Liang, First Affiliated Hospital of Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06888674
- Sponsor's protocol ID
- CISPD-11
- Status last verified
- Mar 2025
- First submitted
- 15 Mar 2025
- Last updated
- 21 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT06888674
- Acronym / sponsor ID
- CISPD-11
- Conditions
- Pancreatic Cancer Resectable
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Collaborators
- Hangzhou Neoantigen Therapeutics Co., Ltd.
- Study start
- 1 Apr 2025 (estimated)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Apr 2029 (estimated)
- First posted
- 21 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A (Chemotherapy-Tolerant Patients) | Experimental | Biological: individualized anti-tumor new antigen iNeo-Vac-R01 injection, Drug: Gemcitabine + Capecitabine, Drug: Sintilimab injectionPostoperative 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. |
| Arm B (Chemotherapy-Intolerant or Chemotherapy-Declined Patients) | Experimental | Biological: individualized anti-tumor new antigen iNeo-Vac-R01 injection, Drug: Sintilimab injectionPostoperative evaluation will be conducted within 4-12 weeks after surgery, and patients without recurrence will be enrolled. For patients who are Chemotherapy-Intolerant or Chemotherapy-Declined, postoperative treatment consists of Sintilimab (200 mg via intravenous infusion) administered Q3W for 8 cycles. On Day 22 ± 3 days, patients will initiate treatment with personalized mRNA injection at a dose of 100 μg administered subcutaneously Q3W, for a maximum of 9 doses. 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 personalized mRNA injection (100 μg subcutaneously,Q3W) and Sintilimab (200 mg via intravenous infusion, Q3W). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Pre-Screening Phase Inclusion Criteria (for Radical Surgery and Vaccine Preparation):
- Formal Screening Phase Inclusion Criteria (for Study Treatment Initiation):
Key exclusion criteria (26 listed)
- 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:
- Active bacterial/fungal infections requiring systemic treatment, or active/latent tuberculosis (confirmed by interferon-gamma release assay or tuberculin skin test);
- Active viral infections:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| individualized anti-tumor new antigen iNeo-Vac-R01 injectionThe individualized anti-tumor new antigen iNeo-Vac-R01 injection was commissioned by Hangzhou Neoantigen Therapeutics Co., Ltd., and all patients were admitted into the therapeutic intervention group. According to the results of previous non-clinical studies, the individualized mRNA injection of 100 μ g was a tolerable dose. | Biological | Arm A (Chemotherapy-Tolerant Patients), Arm B (Chemotherapy-Intolerant or Chemotherapy-Declined Patients) |
| Gemcitabine + CapecitabineGemcitabine: 1000 mg/m², administered intravenously over 30 minutes on Day 1 and Day 8; Capecitabine: 1650-2000 mg/(m²·day), divided into two daily oral doses from Day 1 to Day 14. Treatment cycles repeat every 3 weeks for 8 cycles, with the actual number of cycles determined by the investigator based on comprehensive evaluation of the patient's physical status, disease progression, and adverse reactions. | Drug | Arm A (Chemotherapy-Tolerant Patients) |
| Sintilimab injectionSintilimab Injection, 200mg, intravenous infusion, every 3 weeks | Drug | Arm A (Chemotherapy-Tolerant Patients), Arm B (Chemotherapy-Intolerant or Chemotherapy-Declined Patients) |
Primary outcome
Occurence and frequence of AE and SAE
Time frame: Up to 2 years
Occurence and frequence of Adverse Event (AE) and Serious Adverse Event (SAE) (NCI CTCAE 5.0)
10 secondary outcomes
Recurrence-Free Survival (RFS)
Time frame: Up to 2 years
Recurrence-Free Survival Rate (RFS%)
Time frame: Up to 3 years
Overall Survival (OS)
Time frame: Up to 4 years
Overall Survival Rate (OS%)
Time frame: Up to 3 years
Efficacy Evaluation Metrics for Patients with Recurrence: Objective Response Rate (ORR)
Time frame: Up to 3 years
Efficacy Evaluation Metrics for Patients with Recurrence: Disease Control Rate (DCR)
Time frame: Up to 3 years
Efficacy Evaluation Metrics for Patients with Recurrence: Progression-Free Survival (PFS)
Time frame: Up to 3 years
Efficacy Evaluation Metrics for Patients with Recurrence: Progression-Free Survival Rate (PFS%)
Time frame: Up to 3 years
Efficacy Evaluation Metrics for Patients with Recurrence: Overall Survival (OS)
Time frame: Up to 4 years
Efficacy Evaluation Metrics for Patients with Recurrence: Overall Survival Rate (OS%)
Time frame: Up to 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing individualized anti-tumor new antigen iNeo-Vac-R01 injection, Gemcitabine + Capecitabine and Sintilimab injection in people with Pancreatic Cancer Resectable, run by Zhejiang University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tingbo Liang, MD., PhD. (+8619941463683, liangtingbo@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurence and frequence of AE and SAE (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2025; AzTrials last refreshed its copy on 8 Nov 2026.