To hear about similar clinical trials, please enter your email below
Trial Title:
Clinical Study of XP-004 Personalized mRNA Tumor Vaccine Combined With PD-1 Inhibitor for Postoperative Adjuvant Therapy for Pancreatic Cancer in Patients With Advanced Solid Tumors
NCT ID:
NCT06496373
Condition:
Pancreatic Cancer Recurrent
Conditions: Official terms:
Pancreatic Neoplasms
Conditions: Keywords:
Personalized
Neoantigen
Pancreatic cancer
Post-operative prevention
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
Personalized tumor preventive vaccines
Description:
Personalised mRNA vaccine combined with PD-1 inhibitor treatment every 3 weeks, 3 weeks
as a treatment cycle, a total of 13 cycles.
Arm group label:
Personalized neoantigen vaccine + PD-1
Summary:
The main purpose of this study is to observe and evaluate the safety and tolerance of
XP-004 personalized mRNA vaccine encoding tumor neoantigen combined with PD-1 inhibitor
for adjuvant treatment of patients who cannot tolerate chemotherapy after radical
resection of pancreatic cancer.
The secondary objective was to observe the initial efficacy of adjuvant therapy with
XP-004 personalized mRNA vaccine combined with PD-1 inhibitor in patients with pancreatic
cancer after radical surgery by the indicators of XP-004 personalized mRNA vaccine
induced activstion of Antigen specific CD4 and CD8 T cells, Recurrence free survival
(RFS), and Overall Survival (OS).
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Subjects voluntarily signed written informed consent files,Able to comply with the
study protocol, in the investigator's judgment
2. Subjects must be >/= 18 years of age at time of informed consent, regardless of
gender
3. Patients who have been confirmed by pathology to have pancreatic malignant tumors
and have undergone radical surgery for pancreatic malignant tumors for 1-3 months
4. No copy number variations (CNVs) or loss of heterozygosity (Loss-of heterozygosity,
LOH) were found in HLA-related genes and chromosomal regions by gene sequencing
5. Having tumor tissue confirmed by immunohistochemistry, capable of performing WES and
RNAseq sequencing, and predicted by bioinformatics analysis, it was found that there
is at least one antigen in the table that has been effectively presented by
self-HLA, such as KRAS or TP53 mutations and corresponding HLA subtypes
6. According to the investigator's assessment, the patient is unable to tolerate
chemotherapy, such as the score of the Eastern Cooperative Oncology Group (ECOG)
Performance Scale ≥ 2 points
Exclusion Criteria:
1. Has had chemotherapy, hormone therapy, traditional Chinese medicine, or biological
cancer(for mitomycin and nitrosoureas within 6 weeks from the first dose of the drug
in this study)， prior to the first dose of study therapytherapy within 4 weeks ,Or
within 5 half-lives of immunotherapy, molecular targeted therapy
2. History of interstitial lung disease (ILD), pulmonary fibrosis
3. Other serious and/or uncontrollable diseases, which may affect the subject's
participation in this study, include but not limited to a) a history of severe drug
allergy, or is known to be allergic to any tumor vaccine and pembrolizumab
formulation components or has had severe allergic reactions to other monoclonal
antibodies in the past, b) A history of immunodeficiency, including HIV positive or
other acquired or congenital immunodeficiency diseases
4. Researchers believe that there are other reasons that are not suitable for
participating in clinical trials
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Ruijin Hospital Shanghai Jiaotong University School of Medicine
Address:
City:
Shanghai
Zip:
200025
Country:
China
Status:
Recruiting
Contact:
Last name:
Baiyong Shen, Ph.D&M.D
Phone:
0086-021-64370045
Investigator:
Last name:
Baiyong Shen, Ph.D&M.D
Email:
Principal Investigator
Start date:
April 1, 2024
Completion date:
March 31, 2027
Lead sponsor:
Agency:
Ruijin Hospital
Agency class:
Other
Collaborator:
Agency:
Shanghai Xinpu BioTechnology Company Limited
Agency class:
Other
Source:
Ruijin Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06496373
