Clinical trial NCT03558945: Clinical Trial on Personalized Neoantigen Vaccine for Pancreatic Tumor
Official title: Clinical Trial to Evaluate Safety and Effect of Personalized Neoantigen Vaccine for Pancreatic Tumor Following Surgical Resection and Adjuvant Chemotherapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Pancreatic Tumor
Keywords: pancreatic tumor
neoantigen
vaccine
Lead sponsor: Anda Biopharmaceutical Development (Shenzhen) Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2018-06-15
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

1. Pathologic diagnosis of pancreatic ductal adenocarcinoma
2. Aged ≥20 and ≤75
3. Male or not pregnant women
4. Undergone radical resection (R0 status of resection margins \[no cancer cells within 1 mm of all resection margins\])
5. No serious underlying disease, Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
6. No chemotherapy or radiotherapy before resection surgery
7. No significant cardiac, lung, liver, kidney, and bone marrow insufficiency
8. No HIV or syphilis infection
9. Signing informed consent

Exclusion Criteria:

1. Poor postoperative situation
2. Obvious organ dysfunction
3. Radiographically confirmed recurrence or metastasis within 180 days after the surgery
4. Unstable angina pectoris, symptomatic congestive heart failure, severe arrhythmias, Myocardial infarction in the past 6 months, and prolonged QT interval (\> 450ms)
5. Previous malignant tumors other than pancreatic cancer
6. Cannot be follow up
7. Participating in other clinical trials
8. Without chemotherapy after resection surgery

Exit criteria:

1. Missed within one month after surgery or not follow-up as required
2. Patient's own willingness to withdraw
3. Concurrent disease or severe adverse events
4. Protocol violations
5. Administrative reasons

Primary outcomes:
measure: Incidence and grades of adverse events as assessed by CTCAE v5.0
timeFrame: From the first dose of vaccination through 2 years after the surgery
Secondary outcomes:
measure: Recurrence-free survival
timeFrame: 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.
measure: Overall survival
timeFrame: 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.
measure: Serum CA19-9 or CA72-4 levels
timeFrame: 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.
Other outcomes:
measure: Levels of interferon-γ responses in peripheral blood mononuclear cells
timeFrame: From the date of first dose of vaccination through 264 days after the first dose of vaccination.
measure: Percentages of immune cell populations in peripheral blood during the vaccination
timeFrame: From the date of first dose of vaccination through 264 days after the first dose of vaccination.
Locations:
city: Shanghai
country: China
facility: Changhai Hospital
state: Shanghai
Study officials:
affiliation: Changhai Hospital, Shanghai, China
name: Gang Jin, Doctor
role: PRINCIPAL_INVESTIGATOR
References: