Pancreatic Cancer MetastaticPhase 1/2NCT06888648
Personalized Tumor Neoantigen MRNA Therapy for Advanced Pancreatic Cancer.
A Phase 1/2 study testing individualized anti-tumor new antigen iNeo-Vac-R01 injection, mFOLFIRINOX Treatment Regimen and Sintilimab injection in people with Pancreatic Cancer Metastatic and Pancreatic Cancer Non-resectable, run by Zhejiang University at 1 site in China.
Trial summary
This study is a single-arm phase I/II clinical study to evaluate the effectiveness of evaluate the feasibility and safety of personalized tumor neoantigen mRNA therapy (iNeo-Vac-R01) in combination with PD-1 antibody and standard chemotherapy regimens for the treatment of patients with advanced pancreatic cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pancreatic Cancer Metastatic, Pancreatic Cancer Non-resectable
- What is being tested?
- individualized anti-tumor new antigen iNeo-Vac-R01 injection, mFOLFIRINOX Treatment Regimen and Sintilimab injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2025to 1 Apr 2028
- 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
- Subjects who meet all the following entry criteria enter the pre-screening phase of the study:
- Voluntary signing of the informed consent form;
- Age: 18 and 75 years old, male or female;
- Evaluation as metastatic pancreatic cancer or postoperative recurrence according to the 2024 NCCN guidelines;
- No systemic treatment, or disease progression with gemcitabine-based first-line chemotherapy.
- An Eastern Cooperative Oncology Group (ECOG) physical fitness status score of 0 or 1;
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- According to the efficacy evaluation criteria for solid tumors (RECIST 1.1);
- Can obtain sufficient fresh tumor tissue samples for exome and transcriptome sequencing analysis;
- Main organ function of heart, liver and kidney is normal:
- Ferproductive men and women of childbearing age agree to take effective contraception from the date to the last dose of test drug; women of childbearing age included premenopause and women within 2 years after menopause;
- Ability to follow the study protocol and follow-up procedures.
- Subjects who meet all the following enrollment criteria enter the formal screening stage of the study and enter the study medication process:
- Voluntary signing of the informed consent form;
- Age: 18 and 75 years old, male or female;
- Pancreatic ductal adenocarcinoma (PDAC) diagnosed by pathology (histology or cytology);
- No systemic treatment or gemcitabine-based first-line chemotherapy.
- An Eastern Cooperative Oncology Group (ECOG) physical fitness status score of 0 or 1;
- Main organ function of heart, liver and kidney is normal:
- Ferproductive men and women of childbearing age agree to take effective contraception from the date to the last dose of test drug; women of childbearing age include premenopause and women within 2 years after menopause;
- Ability to follow the study protocol and follow-up procedures.
Who cannot join
- Subjects will be excluded from this study if they meet any of the following criteria:
- Pancreatic cancer has central nervous system metastasis or meningeal metastasis;
- At the same time with other malignant tumors, but cured basal cell cancer, thyroid cancer, cervical dysplasia, etc., have been in the disease for more than 5 years or do not considered to be easy to relapse except;
- History of bone marrow transplantation, allogeneic organ transplantation, or allogeneic hematopoietic stem cell transplantation;
- Patients with immunosuppressants, that is, those who require regular use of immunosuppressants 4 weeks before the screening period and the clinical study, including but not limited to the following conditions: severe asthma, autoimmune diseases or immune deficiency, treated with immunosuppressive drugs, and known history of primary immunodeficiency; except type 1 diabetes, autoimmune-related hypothyroidism requiring hormone therapy, vitiligo and psoriasis that do not require systemic therapy;
- Active bacterial or fungal infection identified by clinical diagnosis; a history of active TB or tuberculosis;
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- Patients with positive human immunodeficiency virus (HIV) antibody, positive treponema pallidum for syphilis (TP) antibody, active hepatitis C (positive hepatitis C virus (HCV) antibody and positive HCV RNA result), active hepatitis B;
- Herpesvirus infection (except those who scab for more than 4 weeks); respiratory virus infection (except those who have recovered for more than 4 weeks);
- Uncontrolled complications include but are not limited to active infection, symptomatic congestive heart failure, unstable angina, arrhythmia; severe coronary artery disease or cerebrovascular disease, or other diseases considered unacceptable by the investigator;
- Previous history of drug abuse, clinical or psychological or social factors affecting informed consent or study implementation; a history of mental illness;
- Patients with a history of food, drug or vaccine allergy or other potential immunotherapy allergies as considered by the Investigator.
- Women born during pregnancy or lactation;
- The investigator is not fit for enrollment or may not complete the trial for other reasons.
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, 31000
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 in Combination with PD-1 Antibody and Chemotherapy for Advanced Pancreatic Cancer.
This study is a single-arm phase I/II clinical study to evaluate the effectiveness of evaluate the feasibility and safety of personalized tumor neoantigen mRNA therapy (iNeo-Vac-R01) in combination with PD-1 antibody and standard chemotherapy regimens for the treatment of patients with advanced pancreatic cancer.
- Being tested
- individualized anti-tumor new antigen iNeo-Vac-R01 injection, mFOLFIRINOX Treatment Regimen, 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 Nuanjin Biotechnology 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.
mFOLFIRINOX Treatment RegimenDrug
continuous intravenous infusion of fluorouracil 2400mg / m², for 46 hours, leucovorin 400mg / m², irinotecan 135mg / m², and oxaliplatin 68mg / m², every 2 weeks
Sintilimab injectionDrug
Sintilimab Injection, 200mg, intravenous infusion, every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | On D1 patients start the mFOLFIRINOX every 2 weeks, and the actual number of cycles of mFOLFIRINOX will be determined by the investigators according on the patients' physical condition, disease progression, adverse effects; on the same day, started Sintilimab, 200mg, intravenous infusion, every 3 weeks; On D43 ± 3, the first efficacy assessment will be conducted. Patient with no disease progression, will continue the above treatment (mFOLFIRINOX Q2W + Sintilimab Q3W + individualized neoantigen mRNA injection Q3W); if disease progression, the patient will receive the second-line chemotherapy regimen (decided by investigators)+ Sintilimab Q3W + individualized neoantigen mRNA injection Q3W. Patients will receive efficacy assessment every 6 weeks. Receives: Biological: individualized anti-tumor new antigen iNeo-Vac-R01 injection; Drug: mFOLFIRINOX Treatment Regimen; 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 (6)
Objective reponse rate (ORR)
The proportion of patients who had tumor evaluated as PR according to RECIST1.1 criteria during the whole study
Measured: Up to 2 years
Disease control rate (DCR)
The proportion of patients who had tumor evaluated as PR or SD according to RECIST1.1 criteria during the whole study.
Measured: Up to 2 years
Progression-free survival （PFS）
The time from enrolled to disease pregression or death from any cause during the whole study.
Measured: Up to 2 years
Overall survival (OS)
The time from enrolled to death from any cause during the whole study
Measured: Up to 2 years
Progression-free survival Rate（1-Y-PFS%, 2-Y-PFS%,3-Y-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
Overall Survival Rate (1-Y-OS%,2-Y-OS%,3-Y-OS%)
The percentage 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 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Cancer MetastaticStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 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
- NCT06888648
- Sponsor's protocol ID
- CISPD-10
- 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 in Combination with PD-1 Antibody and Chemotherapy for Advanced Pancreatic Cancer.
- ClinicalTrials.gov ID
- NCT06888648
- Acronym / sponsor ID
- CISPD-10
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 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 2028 (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-arm phase I/II clinical study to evaluate the effectiveness of evaluate the feasibility and safety of personalized tumor neoantigen mRNA therapy (iNeo-Vac-R01) in combination with PD-1 antibody and standard chemotherapy regimens for the treatment of patients with advanced pancreatic cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Biological: individualized anti-tumor new antigen iNeo-Vac-R01 injection, Drug: mFOLFIRINOX Treatment Regimen, Drug: Sintilimab injectionOn D1 patients start the mFOLFIRINOX every 2 weeks, and the actual number of cycles of mFOLFIRINOX will be determined by the investigators according on the patients' physical condition, disease progression, adverse effects; on the same day, started Sintilimab, 200mg, intravenous infusion, every 3 weeks; On D43 ± 3, the first efficacy assessment will be conducted. Patient with no disease progression, will continue the above treatment (mFOLFIRINOX Q2W + Sintilimab Q3W + individualized neoantigen mRNA injection Q3W); if disease progression, the patient will receive the second-line chemotherapy regimen (decided by investigators)+ Sintilimab Q3W + individualized neoantigen mRNA injection Q3W. Patients will receive efficacy assessment every 6 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Subjects who meet all the following entry criteria enter the pre-screening phase of the study:
- Voluntary signing of the informed consent form;
- Age: 18 and 75 years old, male or female;
- Evaluation as metastatic pancreatic cancer or postoperative recurrence according to the 2024 NCCN guidelines;
- No systemic treatment, or disease progression with gemcitabine-based first-line chemotherapy.
Key exclusion criteria (13 listed)
- Pancreatic cancer has central nervous system metastasis or meningeal metastasis;
- At the same time with other malignant tumors, but cured basal cell cancer, thyroid cancer, cervical dysplasia, etc., have been in the disease for more than 5 years or do not considered to be easy to relapse except;
- History of bone marrow transplantation, allogeneic organ transplantation, or allogeneic hematopoietic stem cell transplantation;
- Patients with immunosuppressants, that is, those who require regular use of immunosuppressants 4 weeks before the screening period and the clinical study, including but not limited to the following conditions: severe asthma, autoimmune diseases or immune deficiency, treated with immunosuppressive drugs, and known history of primary immunodeficiency; except type 1 diabetes, autoimmune-related hypothyroidism requiring hormone therapy, vitiligo and psoriasis that do not require systemic therapy;
- Active bacterial or fungal infection identified by clinical diagnosis; a history of active TB or tuberculosis;
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 Nuanjin Biotechnology 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 |
| mFOLFIRINOX Treatment Regimencontinuous intravenous infusion of fluorouracil 2400mg / m², for 46 hours, leucovorin 400mg / m², irinotecan 135mg / m², and oxaliplatin 68mg / m², every 2 weeks | Drug | Arm A |
| Sintilimab injectionSintilimab Injection, 200mg, intravenous infusion, every 3 weeks | Drug | Arm A |
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)
6 secondary outcomes
Objective reponse rate (ORR)
Time frame: Up to 2 years
Disease control rate (DCR)
Time frame: Up to 2 years
Progression-free survival （PFS）
Time frame: Up to 2 years
Overall survival (OS)
Time frame: Up to 2 years
Progression-free survival Rate（1-Y-PFS%, 2-Y-PFS%,3-Y-PFS%）
Time frame: Up to 3 years
Overall Survival Rate (1-Y-OS%,2-Y-OS%,3-Y-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, mFOLFIRINOX Treatment Regimen and Sintilimab injection in people with Pancreatic Cancer Metastatic and Pancreatic Cancer Non-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 20 inclusion and 13 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.