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NCT Number: NCT07271823

Establishment of a Predictive Model for Immunotherapy Response in Pancreatic Cancer

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Pancreatic Cancer Non-resectable

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: 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.

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;
  • 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.

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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

  1. 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
2024
Primary completion
2026
Study completion
2026
First posted
Dec 9, 2025
Registry last updated
Dec 9, 2025

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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