Construction of a Predictive Model for the Efficacy of Chemoprevention Combined With Targeted Therapy in Pancreatic Cancer
Overview
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Zhejiang Cancer Hospital
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- Objective Best Tumor Response
Overview
Brief Summary
This study is a single-center, observational clinical trial designed to enroll a total of 70 pancreatic cancer patients. Tumor tissue sections from 60 patients will be retrospectively collected to establish a treatment response prediction model using spatial transcriptomics and other analyses. Fresh tumor tissue and blood samples from 10 patients will be prospectively collected to establish pancreatic cancer organoids and humanized immunocompetent mouse models for functional validation and exploration of the underlying molecular mechanisms.
Detailed Description
Primary Objective: Based on a cohort of pancreatic cancer patients receiving combined chemotherapy with immunotherapy and targeted therapy, analyze tumor microenvironment characteristics through multiplex immunohistochemistry and spatial transcriptomics. Identify key biomarkers associated with treatment efficacy and prognosis, and establish a clinically applicable predictive model for treatment outcomes in pancreatic cancer patients undergoing combined chemotherapy with immunotherapy and targeted therapy.
Secondary Objectives: Establish pancreatic cancer organoids and humanized immunocompetent mouse models to functionally validate the aforementioned efficacy prediction model and explore the molecular mechanisms by which the tumor microenvironment modulates treatment response.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age 18 years or older
- •Pathologically and radiologically confirmed pancreatic cancer
Exclusion Criteria
- •Active malignancy other than pancreatic malignancy within the past 5 years or concurrently
Outcomes
Primary Outcomes
Objective Best Tumor Response
Time Frame: 12 months
Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria.
Overall Survival
Time Frame: 60 months
Overall survival is the duration from diagnosis to death. For patients who are alive, overall survival is censored at the last contact.
Secondary Outcomes
- Progression-free Survival(36 months)
Investigators
Ying Jieer
MD
Zhejiang Cancer Hospital