NCT07271823

Establishment of a Predictive Model for Immunotherapy Response in Pancreatic Cancer

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Zhejiang Cancer Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This project aims to establish a single-center, prospective, observational clinical cohort for pancreatic cancer immunotherapy. It plans to enroll 100 patients with advanced pancreatic cancer, collecting tumor tissue sections, plasma, serum, and fecal samples. Through multi-omics analysis including proteomics, metabolomics, and microbiomics, the project will develop predictive models for immunotherapy response.

Detailed description

Primary Objective: Establish a cohort for immunotherapy combined with chemotherapy in advanced pancreatic cancer, ultimately developing predictive models for immunotherapy response based on proteomics, metabolomics, and microbiome data. Secondary Objectives: Map the clinical and genomic/metabolomic/microbiome profiles of patients with advanced pancreatic ductal adenocarcinoma, evaluate the therapeutic efficacy of immunotherapy combined with chemotherapy, and explore potential biomarkers for predicting immunotherapy response.

Conditions

• Pancreatic Cancer Non-resectable

Interventions

Type	Name	Description
OTHER	Sample Collection	Prior to treatment initiation (baseline), collect tissue specimens from the patient's pancreatic cancer or liver metastases via ultrasound-guided biopsy. Simultaneously collect one tube of EDTA-anticoagulated peripheral blood, one tube of clotting-anticoagulant peripheral blood, and one stool sample. Collect peripheral blood and stool samples at key time points including initial assessment, second assessment, and disease progression. Plasma and serum were extracted from the two tubes of peripheral blood. Concurrently, clinical and pathological parameters (age, sex, tumor TNM staging, pathological findings, etc.) and follow-up prognostic information (recurrence status, survival time) were recorded.

Timeline

• Start date: 2024-09-01
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2025-12-09
• Last updated: 2025-12-09

Locations

1 site across 1 country: China