Establishment of a Predictive Model for Immunotherapy Response in Pancreatic Cancer

NCT ID: NCT07271823

Last Updated: 2025-12-09

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-09-01
• Study Completion Date: 2026-12-31

Brief 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

Study Design

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

Study Groups

Locally advanced or metastatic pancreatic ductal adenocarcinoma

Locally advanced or metastatic pancreatic ductal adenocarcinoma in patients who have not previously received systemic anticancer therapy

Sample Collection

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Age 18 years or older;

2. Histologically or cytologically confirmed locally advanced or metastatic pancreatic ductal adenocarcinoma that is unresectable;

3. No prior systemic anticancer therapy;

4. At least one measurable lesion confirmed according to RECIST 1.1 criteria;

5. Receiving first-line treatment with an immunotherapy combined with chemotherapy regimen;

6. Signed informed consent.

Exclusion Criteria

1. Active malignancy other than pancreatic cancer within the past 5 years or concurrently;

2. Prior receipt of immunotherapy or anti-angiogenic therapy.

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

Sponsors

Zhejiang Cancer Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ying Jieer

Principal Investigator

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-2024-974（IIT）

Identifier Type: -

Identifier Source: org_study_id