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.

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Key information

Conditions

Pancreatic Cancer Resectable Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Cancer Non-resectable Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Zhejiang, Hangzhou, 310022, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sample collection

Other

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.

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

Time frame: 36 months

The period from diagnosis until disease progression or death on study, whichever occurred first.

Sponsors and collaborators

Lead sponsor

Zhejiang Cancer Hospital

Other

Registry information

Important dates

Study start: 2025
Primary completion: 2027
Study completion: 2027
First posted: Jan 8, 2026
Registry last updated: Jan 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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