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L'essai clinique NCT07271823 pour Cancer du pancréas non résécable est actif, ne recrute pas. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici. | ||
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Establishment of a Predictive Model for Immunotherapy Response in Pancreatic Cancer 100 Immunothérapie Observationnel
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L'essai clinique NCT07271823 est une étude observationnel pour Cancer du pancréas non résécable. Son statut actuel est : actif, ne recrute pas. L'étude a débuté le 1 septembre 2024 et vise à recruter 100 participants. Dirigée par Zhejiang Cancer Hospital, l'étude devrait être terminée d'ici le 31 décembre 2026. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 9 décembre 2025.
Résumé succinct
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.
Description détaillée
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 im...
Afficher plusTitre officiel
Establishment of a Predictive Model for Immunotherapy Response in Pancreatic Cancer
Pathologies
Cancer du pancréas non résécableAutres identifiants de l'étude
- IRB-2024-974（IIT）
Numéro NCT
Date de début (réel)
2024-09-01
Dernière mise à jour publiée
2025-12-09
Date de fin (estimée)
2026-12-31
Inscription (estimée)
100
Type d'étude
Observationnel
Statut
Actif, ne recrute pas
Mots clés
Chemotherapy combined with immunotherapy
Pancreatic Cancer Non-resectable
efficacy prediction
Biomarker
Pancreatic Cancer Non-resectable
efficacy prediction
Biomarker
Bras / Interventions
| Groupe de participants/Bras | Intervention/Traitement |
|---|---|
Locally advanced or metastatic pancreatic ductal adenocarcinoma Locally advanced or metastatic pancreatic ductal adenocarcinoma in patients who have not previously received systemic anticancer therapy | Collecte d'échantillons 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 dis...Afficher plus |
Critère principal d'évaluation
Critère secondaire d'évaluation
| Critères d'évaluation | Description de la mesure | Période |
|---|---|---|
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 |
| Critères d'évaluation | Description de la mesure | Période |
|---|---|---|
Progression-free Survival | The period from diagnosis until disease progression or death on study, whichever occurred first. | 36 months |
Assistant à la participation
Critères d'éligibilité
Âges éligibles
Adulte, Adulte âgé
Âge minimum
18 Years
Sexes éligibles
Tous
- 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.
- Active malignancy other than pancreatic cancer within the past 5 years or concurrently;
- Prior receipt of immunotherapy or anti-angiogenic therapy.
Zhejiang Cancer HospitalPartie responsable de l'étude
Ying Jieer, Investigateur principal, Principal Investigator, Zhejiang Cancer Hospital
Aucune donnée de contact disponible
1 Centres de l'étude dans 1 pays
Hangzhou
Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Zhejiang, Hangzhou, 310022, China