Resectable Pancreatic CancerPhase 1NCT04810910
Personalized Neoantigen Vaccine in Pancreatic Cancer Patients Following Surgical Resection and Adjuvant Chemotherapy
A Phase 1 study testing iNeo-Vac-P01 and GM-CSF in people with Resectable Pancreatic Cancer, run by Zhejiang Provincial People's Hospital at 1 site in China.
Trial summary
This research study is evaluating a new type of pancreatic cancer vaccine called "Personalized Neoantigen Cancer Vaccine" as a possible treatment for pancreatic cancer patients following surgical resection and adjuvant chemotherapy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Resectable Pancreatic Cancer
- What is being tested?
- iNeo-Vac-P01 and GM-CSF
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 30 Mar 2021to 30 Mar 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must freely sign informed consent;
- Aged 18 to 70 years old;
- Histologically or cytologically confirmed diagnosis of pancreatic adenocarcinoma;
- Must provide all exons of tumor tissue sequencing data, transcriptome sequencing data and the peripheral blood of all exons sequencing data;
- ECOG score is 0 or 1;
- Completed an R0 or R1 surgical resection as determined by pathology；
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- Completion of at least 4 months of adjuvant chemotherapy with ticgio monotherapy or mFOLFIRINOX;
- Completion of imaging records 1 week before personalized immunotherapy, including but not limited to full-body PET-CT and brain MRI,
- The end of chemotherapy is followed by a one-week natural washout period；
- Haematological index：
- White blood cells ≥ 3500 / MCL
- Lymphocytes > 800/ MCL
- neutrophils > 1500/ MCL
- Platelets > 100000 / MCL
- Hemoglobin >10.0g/dL
- Total serum bilirubin <1.5× upper limit of normal value (ULN)
- AST/ALT<2.0 times the upper limit of normal
- Serum creatinine <1.5 times the upper limit of normal；
- Pregnant, lactating women and women of child-bearing age must have a negative pregnancy test within 7 days before entering the group, and short-term have no fertility plan, and are willing to take protective measures (contraception or other birth control methods) before and during the clinical trial;
- Good compliance, able to follow research protocols and follow-up procedures.
Who cannot join
- Evidence of disease recurrence or metastasis following surgical resection at any time prior to the first vaccination administration.
- Diagnosed as other malignant tumor;
- No neoantigen was found in the sequencing data;
- There have been bone marrow or stem cell transplants;
- Received systemic glucocorticoids with immunosuppressants;
- Received other polypeptide inoculation 4 weeks before treatment; Patients may not be vaccinated with other polypeptides 8 weeks after the last individualized tumor targeted polypeptides trentment;
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- With HIV, HCV, HBV infection, severe asthma, autoimmune disease, immunodeficiency or treated with immunosuppressive drugs;
- Uncontrolled complications include, but are not limited to, active infection, symptomatic congestive heart failure, unstable angina pectoris, and arrhythmias;
- Infected with herpes virus (except those with scabs of more than 4 weeks)；
- Infected with respiratory virus (except those who have recovered for more than 4 weeks);
- Have severe coronary or cerebrovascular disease, or other conditions considered ineligible by the investigator;
- Drug abuse. Clinical, psychological or social factor result in affecting informed consent or research implementation;
- Have a history of drug or polypeptide allergies, or people who are allergic to other potential immunotherapies.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang
Yang Liu, M.D., 13666601475, yangliuqq2003@163.com
About this study
Official title: Clinical Study of a Personalized Neoantigen Vaccine in Pancreatic Cancer Patients Following Surgical Resection and Adjuvant Chemotherapy
This research study is evaluating a new type of pancreatic cancer vaccine called "Personalized Neoantigen Cancer Vaccine" as a possible treatment for pancreatic cancer patients following surgical resection and adjuvant chemotherapy. The purpose of the clinical study is evaluating the safety, tolerability and partial efficacy of the personalized neoantigen cancer vaccine in the treatment of resectable pancreatic cancer, so as to provide a new personalized therapeutic strategy.
It is known that cancer patients have mutations (changes in genetic material) that are specific to an individual patient and tumor. These mutations can cause the tumor cells to produce proteins that appear very different from the body's own cells. It is possible that these proteins used in a vaccine may induce strong immune responses, which may help the participant's body fight any tumor cells that could cause the cancer to come back in the future. The study will examine the safety of the vaccine when given at several different time points and will examine the participant's blood cells for signs that the vaccine induced an immune response.
- Conditions
- Resectable Pancreatic Cancer
- Being tested
- iNeo-Vac-P01, GM-CSF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iNeo-Vac-P01Biological
Also called Neoantigen peptides
iNeo-Vac-P01 (peptides)： 300 mcg per peptide
GM-CSFOther
Also called immune adjuvant, granulocyte-macrophage colony stimulating factor
GM-CSF: 40 mcg
| Study group | Role | What they receive |
|---|---|---|
| Personalized neoantigen vaccines | Experimental | iNeo-Vac-P01 (peptides)： 4 x 300 mcg per peptide given on days 1, 4, 8, 15, 22, 52, and 82 for a total of 7 doses;
GM-CSF: 4 x 40 mcg (total dose 160 mcg) given on days 1, 4, 8, 15, 22, 52, and 82 for a total of 7 doses Receives: Biological: iNeo-Vac-P01; Other: GM-CSF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants experiencing clinical and laboratory adverse events (AEs)
Adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events v5.0
Measured: 1 years
Relapse Free Survival(RFS)
Time from surgery to any recurrence
Measured: 4 years
Secondary outcomes (1)
Overall Survival(OS)
Time from surgery to death or last follow-up
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2021
- Study start30 Mar 2021
- Primary completion30 Mar 2025 (estimated)
- Study completion30 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resectable Pancreatic CancerStudies of the same condition, open and under way.
- 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Hangzhou Neoantigen Therapeutics Co., Ltd.
- Responsible party
- Principal investigator, Liu Yang, Zhejiang Provincial People's Hospital
- Investigators
- Yang Liu, Liu, Principal investigator, Zhejiang Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04810910
- Sponsor's protocol ID
- INEO-P-005
- Status last verified
- Nov 2021
- First submitted
- 19 Mar 2021
- Last updated
- 16 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 16 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of a Personalized Neoantigen Vaccine in Pancreatic Cancer Patients Following Surgical Resection and Adjuvant Chemotherapy
- ClinicalTrials.gov ID
- NCT04810910
- Acronym / sponsor ID
- INEO-P-005
- Conditions
- Resectable Pancreatic Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Zhejiang Provincial People's HospitalUniversity, hospital or other
- Collaborators
- Hangzhou Neoantigen Therapeutics Co., Ltd.
- Study start
- 30 Mar 2021 (actual)
- Primary completion
- 30 Mar 2025 (estimated)
- Study completion
- 30 Mar 2025 (estimated)
- First posted
- 23 Mar 2021 (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 research study is evaluating a new type of pancreatic cancer vaccine called "Personalized Neoantigen Cancer Vaccine" as a possible treatment for pancreatic cancer patients following surgical resection and adjuvant chemotherapy. The purpose of the clinical study is evaluating the safety, tolerability and partial efficacy of the personalized neoantigen cancer vaccine in the treatment of resectable pancreatic cancer, so as to provide a new personalized therapeutic strategy.
It is known that cancer patients have mutations (changes in genetic material) that are specific to an individual patient and tumor. These mutations can cause the tumor cells to produce proteins that appear very different from the body's own cells. It is possible that these proteins used in a vaccine may induce strong immune responses, which may help the participant's body fight any tumor cells that could cause the cancer to come back in the future. The study will examine the safety of the vaccine when given at several different time points and will examine the participant's blood cells for signs that the vaccine induced an immune response.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Personalized neoantigen vaccines | Experimental | Biological: iNeo-Vac-P01, Other: GM-CSFiNeo-Vac-P01 (peptides)： 4 x 300 mcg per peptide given on days 1, 4, 8, 15, 22, 52, and 82 for a total of 7 doses; GM-CSF: 4 x 40 mcg (total dose 160 mcg) given on days 1, 4, 8, 15, 22, 52, and 82 for a total of 7 doses |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Must freely sign informed consent;
- Aged 18 to 70 years old;
- Histologically or cytologically confirmed diagnosis of pancreatic adenocarcinoma;
- Must provide all exons of tumor tissue sequencing data, transcriptome sequencing data and the peripheral blood of all exons sequencing data;
- ECOG score is 0 or 1;
Key exclusion criteria (13 listed)
- Evidence of disease recurrence or metastasis following surgical resection at any time prior to the first vaccination administration.
- Diagnosed as other malignant tumor;
- No neoantigen was found in the sequencing data;
- There have been bone marrow or stem cell transplants;
- Received systemic glucocorticoids with immunosuppressants;
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 |
|---|---|---|
| iNeo-Vac-P01Also: Neoantigen peptidesiNeo-Vac-P01 (peptides)： 300 mcg per peptide | Biological | Personalized neoantigen vaccines |
| GM-CSFAlso: immune adjuvant, granulocyte-macrophage colony stimulating factorGM-CSF: 40 mcg | Other | Personalized neoantigen vaccines |
Primary outcome
Number of participants experiencing clinical and laboratory adverse events (AEs)
Time frame: 1 years
Adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events v5.0
Relapse Free Survival(RFS)
Time frame: 4 years
Time from surgery to any recurrence
1 secondary outcome
Overall Survival(OS)
Time frame: 4 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2021.
- 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. This study is not recruiting at the moment.
Yang Liu, Liu principal investigator
Zhejiang Provincial People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing iNeo-Vac-P01 and GM-CSF in people with Resectable Pancreatic Cancer, run by Zhejiang Provincial People's Hospital 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: status not confirmed, as of the sponsor's last update on 16 Nov 2021. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yang Liu, M.D. (13666601475, yangliuqq2003@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants experiencing clinical and laboratory adverse events (AEs) (time frame: 1 years). The study lists 2 primary outcomes in all. 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 16 Nov 2021.