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

NCT ID: NCT07326150

Last Updated: 2026-01-08

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 70 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-12-08
• Study Completion Date: 2027-12-31

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.

Conditions

Pancreatic Cancer Resectable; Pancreatic Cancer Non-resectable

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Pancreatic ductal adenocarcinoma

Pancreatic cancer confirmed by pathology and imaging studies

Sample Collection

Intervention Type: OTHER

1. Blood Sample Collection: Prior to initial treatment, collect one tube of clotting blood (10 ml, serum separator tube) from the patient.

2. 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.

3. Tumor Tissue Sections: Retrospectively collected from our hospital's pathology department, 60 pancreatic cancer patient samples archived over the past 5 years were retrieved.

Interventions

Sample Collection

1. Blood Sample Collection: Prior to initial treatment, collect one tube of clotting blood (10 ml, serum separator tube) from the patient.

2. 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.

3. Tumor Tissue Sections: Retrospectively collected from our hospital's pathology department, 60 pancreatic cancer patient samples archived over the past 5 years were retrieved.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhejiang Cancer Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ying Jieer

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital)

Zhejiang, Hangzhou, China

Countries

China

Other Identifiers

IRB-2025-1714（IIT）

Identifier Type: -

Identifier Source: org_study_id