Establishment of a Predictive Model for Immunotherapy Response in Pancreatic Cancer

University of Chinese Academy Sciences

Status: Active, not recruiting

Conditions: Pancreatic Cancer Non-resectable

Treatments: Other: Sample Collection

Study type: Observational

Funder types: Other

Identifiers

NCT07271823

IRB-2024-974（IIT）

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

100 participants in 1 patient group

Locally advanced or metastatic pancreatic ductal adenocarcinoma

Description:

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

Treatment:

Other: Sample Collection