Construction of a Predictive Model for the Efficacy of Chemoprevention Combined With Targeted Therapy in Pancreatic Cancer

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Pancreatic Cancer Resectable; Pancreatic Cancer Non-resectable
• Intervention / Treatment: Other: Sample Collection

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 Type: Observational
• Enrollment (Estimated): 70

Contacts and Locations

Study Locations

• China
  • Hangzhou
    • Zhejiang, Hangzhou, China, 310022
      • Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Pancreatic cancer confirmed by pathology and imaging studies

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Pancreatic ductal adenocarcinoma; Pancreatic cancer confirmed by pathology and imaging studies

Other: Sample Collection; Blood Sample Collection: Prior to initial treatment, collect one tube of clotting blood (10 ml, serum separator tube) from the patient.; Fresh Tumor Tissue: With informed consent obtained, collect pancreatic cancer or liver metastatic tissue specimens (one 2cm³ surgical specimen or one ≥1cm biopsy specimen) via surgery or biopsy prior to treatment.; Tumor Tissue Sections: Retrospectively collected from our hospital's pathology department, 60 pancreatic cancer patient samples archived over the past 5 years were retrieved.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Best Tumor Response	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.	12 months
Overall Survival	Overall survival is the duration from diagnosis to death. For patients who are alive, overall survival is censored at the last contact.	60 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free Survival	The period from diagnosis until disease progression or death on study, whichever occurred first.	36 months

Collaborators and Investigators

• Sponsor: Zhejiang Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 8, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: December 25, 2025
• First Submitted That Met QC Criteria: December 25, 2025
• First Posted (Actual): January 8, 2026

Study Record Updates

• Last Update Posted (Actual): January 8, 2026
• Last Update Submitted That Met QC Criteria: December 25, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Pancreatic Cancer; efficacy prediction; Organoids; Chemotherapy combined with immunotherapy
• Additional Relevant MeSH Terms: Endocrine System Diseases; Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms; Investigative Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling
• Other Study ID Numbers: IRB-2025-1714（IIT）

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: We currently have no plans to share individual participant data (IPD) with other researchers.