Pancreatic Cancer Non-resectable
Conditions
Keywords
Chemotherapy combined with immunotherapy, Pancreatic Cancer Non-resectable, efficacy prediction, Biomarker
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.
Interventions
OTHERSample 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.
Sponsors
Zhejiang Cancer Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Best Tumor Response | 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. |
| Overall Survival | 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
| Measure | Time frame | Description |
|---|---|---|
| Progression-free Survival | 36 months | The period from diagnosis until disease progression or death on study, whichever occurred first. |
Countries
China
Outcome results
None listed