Pancreatic TumorPhase 1NCT03558945
Clinical Trial on Personalized Neoantigen Vaccine for Pancreatic Tumor
A Phase 1 study testing Personalized neoantigen vaccine in people with Pancreatic Tumor, run by Anda Biopharmaceutical Development (Shenzhen) Co., Ltd. at 1 site in China.
Trial summary
This clinical trial is to evaluate the safety and impact on prognosis of personalized neoantigen peptide-based vaccines, which are based on next-generation sequencing and major histocompatibility complex affinity prediction algorithm, in patients with pancreatic ductal adenocarcinoma. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Pancreatic Tumor
- What is being tested?
- Personalized neoantigen vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 12 Jul 2018to 30 Dec 2023
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologic diagnosis of pancreatic ductal adenocarcinoma
- Aged ≥20 and ≤75
- Male or not pregnant women
- Undergone radical resection (R0 status of resection margins [no cancer cells within 1 mm of all resection margins])
- No serious underlying disease, Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- No chemotherapy or radiotherapy before resection surgery
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- No significant cardiac, lung, liver, kidney, and bone marrow insufficiency
- No HIV or syphilis infection
- Signing informed consent
Who cannot join
- Poor postoperative situation
- Obvious organ dysfunction
- Radiographically confirmed recurrence or metastasis within 180 days after the surgery
- Unstable angina pectoris, symptomatic congestive heart failure, severe arrhythmias, Myocardial infarction in the past 6 months, and prolonged QT interval (> 450ms)
- Previous malignant tumors other than pancreatic cancer
- Cannot be follow up
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- Participating in other clinical trials
- Without chemotherapy after resection surgery
- Exit criteria:
- Missed within one month after surgery or not follow-up as required
- Patient's own willingness to withdraw
- Concurrent disease or severe adverse events
- Protocol violations
- Administrative reasons
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Changhai Hospital
Shanghai, Shanghai Municipality
Shiwei Guo, Doctor, +8618621500666, gestwa@163.com
About this study
Official title: Clinical Trial to Evaluate Safety and Effect of Personalized Neoantigen Vaccine for Pancreatic Tumor Following Surgical Resection and Adjuvant Chemotherapy
This clinical trial is to evaluate the safety and impact on prognosis of personalized neoantigen peptide-based vaccines, which are based on next-generation sequencing and major histocompatibility complex affinity prediction algorithm, in patients with pancreatic ductal adenocarcinoma. The hypothesis of this study is that personalized neoantigen vaccines will be safe and can systemically elicit measurable neoantigen-specific immunologic responses in patients. Participants will receive complete macroscopic resection of primary tumor, standard adjuvant chemotherapy and subsequently personalized neoantigen vaccines.
Read the detailed description
This is a single-center, open-label Phase Ib clinical trial. In this trial, adult subjects with pancreatic ductal adenocarcinoma who have completed resection of the primary tumor and who have not undergone preoperative chemotherapy will be enrolled in the study. Eligible enrolled patients all will undergo tumor resection and all receive adjuvant chemotherapy prior to preparation of the personalized neoantigen vaccine. After the chemotherapy finish, subsequently patients will receive a priming immunization with five doses of the personalized neoantigen vaccine over one month and a boosting immunization with two doses three months later. This clinical trial will examine the safety and effect of the personalized neoantigen vaccine when given at several different time points and will examine the participant's peripheral blood cells for signs that the vaccine induces immunologic responses. Finally we will establish the typical flow to assess efficiency and safety of vaccines according to the different reactivity of patients, as a result, to explore the most suitable practical approaches for applying personalized pancreatic tumor vaccines.
- Conditions
- Pancreatic Tumor
- Being tested
- Personalized neoantigen vaccine
- Keywords
- pancreatic tumor, neoantigen, vaccine
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized neoantigen vaccineBiological
Patients will have complete resection of primary tumor without preoperative chemotherapy. Patients will receive postoperative chemotherapy and subsequently personalized vaccines on days 1, 4, 8, 15, 22 (priming phase) and weeks 12, 20 (boosting phase). Personalized vaccines will consist of several distinct peptides (the dose is 0.3 mg/peptide) that are grouped into 2-4 pools and 0.5 mg of poly-ICLC as the adjuvant for each pool. Injection sites will be 2-4 separate sites of the subject's thighs.
| Study group | Role | What they receive |
|---|---|---|
| Personalized neoantigen vaccine | Experimental | Patients will receive radical resection surgery and at least one circle of post-operative chemotherapy. After chemotherapy, personalized neoantigen vaccines will be administered subcutaneously. Receives: Biological: Personalized neoantigen vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and grades of adverse events as assessed by CTCAE v5.0
Safety will be assessed by the rate of grade 3 or worse adverse events (graded according to National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0).
Measured: From the first dose of vaccination through 2 years after the surgery
Secondary outcomes (3)
Recurrence-free survival
The time between resection surgery and the tumor recurrence (radiological assessment of disease status according to RECIST1.1 criteria).
Measured: From the date of resection surgery until the date of the first confirmed tumor recurrence or date of death from any cause or date of study completion, whichever came first, assessed up to 6 years.
Overall survival
The time between resection surgery and the death (any cause).
Measured: From the date of resection surgery until the date of death from any cause or date of study completion, whichever came first, assessed up to 6 years.
Serum CA19-9 or CA72-4 levels
The rate of patients without the abnormal elevation of the serum CA19-9 (Cancer Antigen 19-9) or CA72-4 (Cancer Antigen 72-4) levels will be assessed during the vaccination and post-treatment follow-up.
Measured: From the date of resection surgery until the date of last documented examination of CA19-9 and CA72-4 or date of study completion, whichever came first, assessed up to 6 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2018
- Study start12 Jul 2018
- Primary completion30 Nov 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic TumorStudies 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anda Biopharmaceutical Development (Shenzhen) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gang Jin, Doctor, Principal investigator, Changhai Hospital, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03558945
- Sponsor's protocol ID
- ChanghaiH-PP03
- Status last verified
- Mar 2023
- First submitted
- 24 May 2018
- Last updated
- 24 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial to Evaluate Safety and Effect of Personalized Neoantigen Vaccine for Pancreatic Tumor Following Surgical Resection and Adjuvant Chemotherapy
- ClinicalTrials.gov ID
- NCT03558945
- Acronym / sponsor ID
- ChanghaiH-PP03
- Conditions
- Pancreatic Tumor
- Keywords
- pancreatic tumor, neoantigen, vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Anda Biopharmaceutical Development (Shenzhen) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 12 Jul 2018 (actual)
- Primary completion
- 30 Nov 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 15 Jun 2018 (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 clinical trial is to evaluate the safety and impact on prognosis of personalized neoantigen peptide-based vaccines, which are based on next-generation sequencing and major histocompatibility complex affinity prediction algorithm, in patients with pancreatic ductal adenocarcinoma. The hypothesis of this study is that personalized neoantigen vaccines will be safe and can systemically elicit measurable neoantigen-specific immunologic responses in patients. Participants will receive complete macroscopic resection of primary tumor, standard adjuvant chemotherapy and subsequently personalized neoantigen vaccines.
Detailed description
This is a single-center, open-label Phase Ib clinical trial. In this trial, adult subjects with pancreatic ductal adenocarcinoma who have completed resection of the primary tumor and who have not undergone preoperative chemotherapy will be enrolled in the study. Eligible enrolled patients all will undergo tumor resection and all receive adjuvant chemotherapy prior to preparation of the personalized neoantigen vaccine. After the chemotherapy finish, subsequently patients will receive a priming immunization with five doses of the personalized neoantigen vaccine over one month and a boosting immunization with two doses three months later. This clinical trial will examine the safety and effect of the personalized neoantigen vaccine when given at several different time points and will examine the participant's peripheral blood cells for signs that the vaccine induces immunologic responses. Finally we will establish the typical flow to assess efficiency and safety of vaccines according to the different reactivity of patients, as a result, to explore the most suitable practical approaches for applying personalized pancreatic tumor vaccines.
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 vaccine | Experimental | Biological: Personalized neoantigen vaccinePatients will receive radical resection surgery and at least one circle of post-operative chemotherapy. After chemotherapy, personalized neoantigen vaccines will be administered subcutaneously. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Pathologic diagnosis of pancreatic ductal adenocarcinoma
- Aged ≥20 and ≤75
- Male or not pregnant women
- Undergone radical resection (R0 status of resection margins [no cancer cells within 1 mm of all resection margins])
- No serious underlying disease, Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Key exclusion criteria (14 listed)
- Poor postoperative situation
- Obvious organ dysfunction
- Radiographically confirmed recurrence or metastasis within 180 days after the surgery
- Unstable angina pectoris, symptomatic congestive heart failure, severe arrhythmias, Myocardial infarction in the past 6 months, and prolonged QT interval (> 450ms)
- Previous malignant tumors other than pancreatic cancer
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 |
|---|---|---|
| Personalized neoantigen vaccinePatients will have complete resection of primary tumor without preoperative chemotherapy. Patients will receive postoperative chemotherapy and subsequently personalized vaccines on days 1, 4, 8, 15, 22 (priming phase) and weeks 12, 20 (boosting phase). Personalized vaccines will consist of several distinct peptides (the dose is 0.3 mg/peptide) that are grouped into 2-4 pools and 0.5 mg of poly-ICLC as the adjuvant for each pool. Injection sites will be 2-4 separate sites of the subject's thighs. | Biological | Personalized neoantigen vaccine |
Primary outcome
Incidence and grades of adverse events as assessed by CTCAE v5.0
Time frame: From the first dose of vaccination through 2 years after the surgery
Safety will be assessed by the rate of grade 3 or worse adverse events (graded according to National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0).
3 secondary outcomes
Recurrence-free survival
Time frame: From the date of resection surgery until the date of the first confirmed tumor recurrence or date of death from any cause or date of study completion, whichever came first, assessed up to 6 years.
Overall survival
Time frame: From the date of resection surgery until the date of death from any cause or date of study completion, whichever came first, assessed up to 6 years.
Serum CA19-9 or CA72-4 levels
Time frame: From the date of resection surgery until the date of last documented examination of CA19-9 and CA72-4 or date of study completion, whichever came first, assessed up to 6 years.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2023.
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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.
Gang Jin, Doctor principal investigator
Changhai Hospital, Shanghai, China
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 Personalized neoantigen vaccine in people with Pancreatic Tumor, run by Anda Biopharmaceutical Development (Shenzhen) Co., Ltd. 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 9 inclusion and 14 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 24 Apr 2023. 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 Shiwei Guo, Doctor (+8618621500666, gestwa@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and grades of adverse events as assessed by CTCAE v5.0 (time frame: From the first dose of vaccination through 2 years after the surgery). 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 24 Apr 2023.