Condition: Pancreatic Ductal Adenocarcinoma (PDAC) · Sponsor: Beijing Daxiang Biotech Co., Ltd
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 responses to anticancer therapies. Several retrospective and prospective studies across various tumor types have demonstrated high sensitivity and specificity for PDO-based drug sensitivity testing in predicting clinical outcomes. However, prospective data specifically focused on pancreatic cancer remain limited. 2. Study Objective The primary objective of this study is to evaluate the concordance between PDO-based drug sensitivity test results and clinical efficacy in PDAC patients receiving standard first-line chemotherapy. Secondary objectives include optimizing culture conditions and drug testing …
This description comes directly from the study's public registry record.
Jiabin Jin, MD · 0086-18917762352 · jjb11501@rjh.com.cn
Zhaohong Wen, PhD · 0086-13522210548 · wenzhaohong@daxiangbio.com
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| Ruijin Hospital | Shanghai, Shanghai Municipality, China | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07683845