Establishment of a Predictive Model for Immunotherapy Response in Pancreatic Cancer

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.

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.

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.