Using patient-derived tumor organoids to predict pre-surgery treatment response in resectable esophageal squamous cell carcinoma
Patient Derived Organoids (PDOs) to Observe the Clinical Consistency of Personalized Neoadjuvant Therapy for Resectable Esophageal Squamous Cell Carcinoma
This project will test whether lab-grown mini-tumors made from each patient's own cancer can predict how their resectable esophageal squamous cell carcinoma will respond to personalized pre-surgery chemotherapy or chemo‑immunotherapy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Shanghai Zhongshan Hospital Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, radiation |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT07054086 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults 18–75 years with histologically confirmed, resectable thoracic esophageal squamous cell carcinoma (AJCC 8th edition, excluding T4b), ECOG 0–1, adequate organ function, and willingness to provide tumor tissue and attend follow-up are ideal candidates.
Not a fit: Patients with unresectable or widely metastatic disease (including T4b), poor performance status, inability to provide a biopsy or to travel for on-site follow-up, or whose tumors fail to grow organoids may not receive benefit from PDO-guided prediction.
Why it matters
Potential benefit: If successful, this approach could help clinicians choose the most effective pre-surgery therapy for each patient, reducing exposure to ineffective treatments and potentially improving surgical and survival outcomes.
How similar studies have performed: Some prior work in other gastrointestinal cancers has shown that PDO drug testing can often predict patient responses, but using PDOs to guide neoadjuvant therapy in esophageal squamous cell carcinoma remains relatively novel with limited clinical validation.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Shanghai, Shanghai Municipality
- Zhongshan Hospital, Fudan University — Shanghai, Shanghai Municipality, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.