Using patient-derived tumor organoids to predict pre-surgery treatment response in resectable esophageal squamous cell carcinoma

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 collects tumor tissue from patients with resectable esophageal squamous cell carcinoma and grows patient-derived organoids (PDOs) in the laboratory. Investigators run drug sensitivity tests on the PDOs using the chemotherapy or chemo‑immunotherapy regimens planned for each patient. PDO results are then compared with the patients' actual clinical responses to neoadjuvant therapy and subsequent surgical/pathologic outcomes. The aim is to determine how consistently PDO responses mirror real-world treatment effectiveness and whether PDO testing could help guide personalized neoadjuvant choices. The study is conducted at Zhongshan Hospital, Fudan University in Shanghai.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Histologically confirmed esophageal squamous cell carcinoma via endoscopic biopsy.
* Primary tumor located in the thoracic esophagus (upper third: ≤25 cm from incisors; middle third: 25-30 cm; lower third: ≥30 cm).
* Clinical staging indicates resectable ESCC based on chest/abdominal enhanced CT, neck lymph node ultrasound, PET-CT/EUS: AJCC/UICC 8th Edition clinical stage excluding T4b, ≥6 lymph node metastases, ≥3 regional lymph node stations involved/metastatic disease (M1).
* Age: 18-75 years inclusive.
* ECOG performance status score of 0 or 1, with life expectancy ≥12 months.
* Adequate organ function: WBC \>4.0×10⁹/L, ANC ≥2.0×10⁹/L, platelets \>100×10⁹/L, hemoglobin \>90g/L; FEV1 ≥1.2L/FVC≥50%/DLCO≥50%; serum bilirubin ≤1.5×ULN; ALT/AST ≤1.5×ULN; SCr ≤120 µmol/L/Ccr ≥60 ml/min.
* Willingness and ability to provide informed consent, comply with follow-up requirements, and participate actively in drug sensitivity testing using PDO models.

Exclusion Criteria:

* Clinical staging indicates unresectable ESCC: AJCC/UICC stage T4b disease deemed inoperable by two senior thoracic surgeons; ≥6 lymph node metastases estimated clinically/regionally involving ≥3 stations with lymphadenopathy/metastasis detected via imaging (CT/PET/EUS).
* Currently receiving/was previously treated with chemotherapy/targeted therapy/radiation/or immunotherapy.
* Histopathologic diagnosis other than ESCC confirmed via biopsy (e.g., adenocarcinoma).
* History of prior malignancies except for cured cervical intraepithelial neoplasia or basal cell carcinoma limited locally.
* Autoimmune disease history; ongoing/recurrent corticosteroid/immunosuppressant use.
* Prior immunotherapy treatment; known allergy to investigational drugs; HIV/HBV(HBeAg)/HCV positivity (serum markers).
* Active interstitial lung disease/bronchiectasis; uncontrolled hypertension (SBP≥160 mmHg or DBP≥100 mmHg); cardiovascular disorders (e.g., active ischemia, arrhythmias requiring treatment).
* Pregnancy/lactation; unwillingness to use contraception during study period.
* Non-compliance with protocol requirements, psychiatric comorbidities affecting consent capacity, or concurrent participation in other clinical trials.
* Organ transplantation history (autologous bone marrow/stem cell transplant excluded).

Where it's running

• Zhongshan Hospital, Fudan University
  Shanghai, Shanghai Municipality, China Recruiting

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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.