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

NCT07326150 | Active Not Recruiting DMC

• 1 other identifier: IRB-2025-1714（IIT）
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cancer Resectable; Pancreatic Cancer Non-resectable

Keywords

Chemotherapy combined with immunotherapy; efficacy prediction; Organoids; Pancreatic Cancer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Progression-free Survival

  36 months

Study Arms (1)

Pancreatic ductal adenocarcinoma

Pancreatic cancer confirmed by pathology and imaging studies

Other: Sample Collection

Interventions

Sample Collection 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.

Pancreatic ductal adenocarcinoma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pancreatic cancer confirmed by pathology and imaging studies

You may qualify if:

• Age 18 years or older
• Pathologically and radiologically confirmed pancreatic cancer

You may not qualify if:

• Active malignancy other than pancreatic malignancy within the past 5 years or concurrently

Sponsors & Collaborators

• Zhejiang Cancer Hospital: lead

Study Sites (1)

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

Zhejiang, Hangzhou, 310022, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Patient tumor tissue sections, blood and fresh tumor tissue

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Specimen Handling

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 25, 2025
• First Posted: January 8, 2026
• Study Start: December 8, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 8, 2026

Record last verified: 2025-12

Locations

CN (1)