Pancreatic CancerPhase 1NCT06344156
Neoantigen Vaccine Plus Anti-PD1 and Chemotherapy as an Adjuvant Therapy for Pancreatic Cancer
A Phase 1 study testing Neoantigen Vaccine Plus Anti-PD1 and Chemotherapy in people with Pancreatic Cancer and Adjuvant Therapy, run by Sichuan University at 1 site in China.
Trial summary
The aim of this single center, single arm and prospective study is to explore the safety and efficacy of Neoantigen Vaccine Plus Anti-PD1 and Chemotherapy in postoperative adjuvant treatment of Pancreatic Cancer Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pancreatic Cancer, Adjuvant Therapy
- What is being tested?
- Neoantigen Vaccine Plus Anti-PD1 and Chemotherapy
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2024to 1 Apr 2027
- Phase
- Phase 1
- 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
- Age ≥18 years and age ≤75 years.
- ECOG score 0-1.
- Patients with histologically confirmed pancreatic ductal adenocarcinoma, R0 resection, stage I-III, not receiving neoadjuvant therapy.
- Adequate bone marrow and organ function:
- Patients of childbearing potential must take appropriate precautions prior to enrollment and during the study.
- Signed informed consent.
- Ability to comply with the study protocol and follow-up.
Who cannot join
- Received antitumor chemotherapy, radiation therapy, or immunotherapy within 2 weeks prior to first vaccination.
- The patient has a history of other tumors, except for cervical cancer in situ, treated squamous cell carcinoma or urothelial tumors (Ta and TIS), or other malignancies that have been treated with curative intent (at least 5 years prior to enrollment).
- Uncontrollable comorbidities, including but not limited to active bacterial or fungal infections, symptomatic congestive heart failure, unstable angina, arrhythmias.
- HIV infection or active hepatitis B (HBV DNA≥500IU/ml), hepatitis C.
- Uncontrolled coronary artery disease or asthma, uncontrolled cerebrovascular disease, or other conditions deemed ineligible by the investigator.
- Uncontrollable comorbidities, including but not limited to active bacterial or fungal infections, congestive heart failure, unstable angina, arrhythmias, etc;
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- Patients with autoimmune diseases or immunodeficiencies being treated with immunosuppressive drugs.
- Pregnant or lactating women.
- Vaccination with other preventive vaccines within 4 weeks before the first administration or planned during the study period, including within 8 weeks after the last vaccination.
- Those who have had a severe allergic reaction to vaccines for other infectious diseases in the past.
- Those who may be allergic to the investigational product or any of its excipients.
- Substance abuse or inability to undergo immunotherapy due to clinical, psychological, or social factors.
- Significant weight loss (≥10%) within 6 weeks prior to enrollment.
- Any uncertain factors that may affect patient safety or compliance.
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, 1 recruiting
- Recruiting
West China Hospital, Sichuan University
Chengdu, Sichuan, 610000
Zhong Wu, MD, 028-85422851, wuzhong5555@126.com
Zhong Wu
About this study
Official title: Adjuvant Therapy of Neoantigen Vaccine Plus Anti-PD1 and Chemotherapy in Patients With Resected Pancreatic Cancer
The aim of this single center, single arm and prospective study is to explore the safety and efficacy of Neoantigen Vaccine Plus Anti-PD1 and Chemotherapy in postoperative adjuvant treatment of Pancreatic Cancer
- Conditions
- Pancreatic Cancer, Adjuvant Therapy
- Being tested
- Neoantigen Vaccine Plus Anti-PD1 and Chemotherapy
- Keywords
- Pancreatic Cancer, Neoantigen, Adjuvant therapy, Safety, Clinical efficacy
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neoantigen Vaccine Plus Anti-PD1 and ChemotherapyDrug
Gemcitabine +capecitabine, tislelizumab, neoantigen vaccines
| Study group | Role | What they receive |
|---|---|---|
| Neoantigen Vaccine Plus Anti-PD1 and Chemotherapy | Experimental | (1)8 cycles of Gemcitabine +capecitabine (Gemcitabine d1,8 ,Capecitabine d1-14 q3w）；（2） two 200 mg intravenous dose of tislelizumab (d1,q3w)（3）five intravenous doses of neoantigen vaccines given as priming doses(d1,8,22,36,50）and two booster dose(d80,d110) Receives: Drug: Neoantigen Vaccine Plus Anti-PD1 and Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
18-month RFS
defined recurrence as new lesions on the basis of response evaluation criteria in solid tumours (v.1.1), and RFS from either the date of surgery (RFS) or from the date of the last neoantigen vaccine priming dose to the date of recurrence or death, whichever occurred first.
Measured: through study completion, an average of 2 year
Incidence of Treatment-Related Adverse Events [Safety and Tolerability]
Defined by treatment-related adverse events as assessed by CTCAE v4.0
Measured: 3 months after the last administration of neoantigen vaccine
Secondary outcomes (1)
18-month OS
defined OS from the date of surgery to the date of death.
Measured: through study completion, an average of 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2024
- Study start1 Apr 2024
- Primary completion1 Apr 2026 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Sichuan 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhen-Yu Ding, Sichuan University
- Investigators
- zhong Wu, MD, Principal investigator, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06344156
- Sponsor's protocol ID
- CHANT-231
- Status last verified
- Feb 2025
- First submitted
- 27 Mar 2024
- Last updated
- 28 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjuvant Therapy of Neoantigen Vaccine Plus Anti-PD1 and Chemotherapy in Patients With Resected Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT06344156
- Acronym / sponsor ID
- CHANT-231
- Conditions
- Pancreatic Cancer, Adjuvant Therapy
- Keywords
- Pancreatic Cancer, Neoantigen, Adjuvant therapy, Safety, Clinical efficacy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 43 participants (estimated)
- Lead sponsor
- Sichuan UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 3 Apr 2024 (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.
The aim of this single center, single arm and prospective study is to explore the safety and efficacy of Neoantigen Vaccine Plus Anti-PD1 and Chemotherapy in postoperative adjuvant treatment of 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 |
|---|---|---|
| Neoantigen Vaccine Plus Anti-PD1 and Chemotherapy | Experimental | Drug: Neoantigen Vaccine Plus Anti-PD1 and Chemotherapy(1)8 cycles of Gemcitabine +capecitabine (Gemcitabine d1,8 ,Capecitabine d1-14 q3w）；（2） two 200 mg intravenous dose of tislelizumab (d1,q3w)（3）five intravenous doses of neoantigen vaccines given as priming doses(d1,8,22,36,50）and two booster dose(d80,d110) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥18 years and age ≤75 years.
- ECOG score 0-1.
- Patients with histologically confirmed pancreatic ductal adenocarcinoma, R0 resection, stage I-III, not receiving neoadjuvant therapy.
- Adequate bone marrow and organ function:
- Patients of childbearing potential must take appropriate precautions prior to enrollment and during the study.
Key exclusion criteria (14 listed)
- Received antitumor chemotherapy, radiation therapy, or immunotherapy within 2 weeks prior to first vaccination.
- The patient has a history of other tumors, except for cervical cancer in situ, treated squamous cell carcinoma or urothelial tumors (Ta and TIS), or other malignancies that have been treated with curative intent (at least 5 years prior to enrollment).
- Uncontrollable comorbidities, including but not limited to active bacterial or fungal infections, symptomatic congestive heart failure, unstable angina, arrhythmias.
- HIV infection or active hepatitis B (HBV DNA≥500IU/ml), hepatitis C.
- Uncontrolled coronary artery disease or asthma, uncontrolled cerebrovascular disease, or other conditions deemed ineligible by the investigator.
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 |
|---|---|---|
| Neoantigen Vaccine Plus Anti-PD1 and ChemotherapyGemcitabine +capecitabine, tislelizumab, neoantigen vaccines | Drug | Neoantigen Vaccine Plus Anti-PD1 and Chemotherapy |
Primary outcome
18-month RFS
Time frame: through study completion, an average of 2 year
defined recurrence as new lesions on the basis of response evaluation criteria in solid tumours (v.1.1), and RFS from either the date of surgery (RFS) or from the date of the last neoantigen vaccine priming dose to the date of recurrence or death, whichever occurred first.
Incidence of Treatment-Related Adverse Events [Safety and Tolerability]
Time frame: 3 months after the last administration of neoantigen vaccine
Defined by treatment-related adverse events as assessed by CTCAE v4.0
1 secondary outcome
18-month OS
Time frame: through study completion, an average of 3 year
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 28 Feb 2025.
- Individual participant dataSharing planned: Yes
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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.
zhong Wu, MD principal investigator
West China 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 Neoantigen Vaccine Plus Anti-PD1 and Chemotherapy in people with Pancreatic Cancer and Adjuvant Therapy, run by Sichuan 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 7 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: looking for participants now, as of the sponsor's last update on 28 Feb 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 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?
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 zhong Wu, MD (028-85422851, wuzhong5555@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
18-month RFS (time frame: through study completion, an average of 2 year). 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 28 Feb 2025.