Establishment of a Predictive Model for Immunotherapy Response in Pancreatic Cancer

NCT07271823 | Active Not Recruiting

• 1 other identifier: IRB-2024-974（IIT）
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cancer Non-resectable

Keywords

Chemotherapy combined with immunotherapy; Pancreatic Cancer Non-resectable; efficacy prediction; Biomarker

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)

Locally advanced or metastatic pancreatic ductal adenocarcinoma

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

Other: Sample Collection

Interventions

Sample Collection 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.

Locally advanced or metastatic 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

Locally advanced or metastatic pancreatic ductal adenocarcinoma confirmed histologically or cytologically as unresectable

You may qualify if:

• Age 18 years or older;
• Histologically or cytologically confirmed locally advanced or metastatic pancreatic ductal adenocarcinoma that is unresectable;
• No prior systemic anticancer therapy;
• At least one measurable lesion confirmed according to RECIST 1.1 criteria;
• Receiving first-line treatment with an immunotherapy combined with chemotherapy regimen;
• Signed informed consent.

You may not qualify if:

• Active malignancy other than pancreatic cancer within the past 5 years or concurrently;
• Prior receipt of immunotherapy or anti-angiogenic therapy.

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, plasma, serum, and stool specimens

MeSH Terms

Interventions

Specimen Handling

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: Principal Investigator

Study Record Dates

• First Submitted: November 26, 2025
• First Posted: December 9, 2025
• Study Start: September 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 9, 2025

Record last verified: 2025-11

Locations

CN (1)