Status:
UNKNOWN
Personalized Neoantigen Vaccine in Pancreatic Cancer Patients Following Surgical Resection and Adjuvant Chemotherapy
Lead Sponsor:
Zhejiang Provincial People's Hospital
Collaborating Sponsors:
Hangzhou Neoantigen Therapeutics Co., Ltd.
Conditions:
Resectable Pancreatic Cancer
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief 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 rese...
Eligibility Criteria
Inclusion
- Inclusion Criteria：
- 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；
- 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.
- Exclusion Criteria:
- 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;
- 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.
Exclusion
Key Trial Info
Start Date :
March 30 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 30 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04810910
Start Date
March 30 2021
End Date
March 30 2025
Last Update
November 16 2021
Active Locations (1)
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1
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China