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Patient-Derived Organoid-on-a-Chip Model for Personalized Prediction of Chemotherapy Efficacy in Pancreatic Cancer

Recruitingn/aAges 18 Years - 75 YearsAllBeijing Daxiang Biotech Co., Ltd
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In plain words

What the trial is, and whether it could suit you

1. Background Pancreatic ductal adenocarcinoma (PDAC) remains one of the most lethal malignancies worldwide, with a 5-year survival rate below 10%. Systemic chemotherapy is the mainstay of treatment for the majority of patients who present with unresectable disease. However, the objective response rates for standard first-line regimens, such as nab-paclitaxel plus gemcitabine (AG) and FOLFIRINOX, are only 15-30%. Currently, there are no validated predictive biomarkers to guide chemotherapy selection, leading to a trial-and-error approach that exposes patients to unnecessary toxicity and delays effective treatment. Patient-derived organoids (PDOs) are three-dimensional in vitro models that recapitulate the genetic, histological, and phenotypic features of their source tumors. PDOs have shown promise as a functional precision medicine platform for predicting individual patient response

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: * Age 18-75 years, both sexes * Pathologically confirmed pancreatic ductal adenocarcinoma (PDAC) in treatment-naïve patients * Ability to obtain sufficient fresh tumor tissue samples for organoid establishment through surgery or biopsy * Planned to receive neoadjuvant therapy for borderline resectable disease, conversion therapy for locally advanced disease, or first-line therapy for metastatic disease, using single-agent or combination chemotherapy * At least one measurable lesion per RECIST 1.1 criteria * ECOG performance status 0-2 * Life expectancy ≥3 months * Adequate organ and bone marrow function: hemoglobin ≥9.0 g/dL; absolute neutrophil count ≥1.5×10⁹/L; platelet count ≥100×10⁹/L; total bilirubin ≤1.5×ULN (or ≤3×ULN with biliary obstruction); ALT/AST ≤2.5×ULN (or ≤5×ULN with biliary obstruction); serum creatinine ≤1.5×ULN or CrCl \>60 mL/min * Willing to sign informed consent, good compliance, and able to comply with follow-up Exclusion Criteria: * Sample quantity, quality, or preservation does not meet requirements * Expected transport time \>24 hours (including samples stored overnight before delivery) * Organoid culture failure or testing quality control failure * Inability to tolerate chemotherapy regimens * Severe comorbidities, uncontrolled conditions, or active infections * Pregnancy or breastfeeding * History of severe autoimmune diseases * Any unstable condition that may compromise patient safety or compliance * Deemed unsuitable for inclusion by the investigator
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What it tests

  • Not listed
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Where

1 site
Ruijin Hospital
Shanghai, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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