Patient-Derived Organoids on a Chip to Predict Chemotherapy Response in PDAC

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study uses patient-derived organoids to simulate tumor response to standard chemotherapy in PDAC. Organoids are integrated with microfluidic chip technology to mirror tumor biology and test drug sensitivity. The goal is to identify potential predictive signatures that could guide first-line or neoadjuvant chemotherapy choices while avoiding ineffective treatments. The study analyzes tissue from treatment-naïve patients and correlates organoid responses with clinical outcomes. No interventional treatment is conducted within the trial itself; the focus is on predictive modeling and correlation with real-world responses.

Why it matters

Who can join: the full rules

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

Where it's running

• Ruijin Hospital
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Jiabin Jin, MD
• Email: jjb11501@rjh.com.cn
• Phone: 0086-18917762352

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.