Patient Derived Organoids (PDOs) to Observe the Clinical Consistency of Personalized Neoadjuvant Therapy for Resectable Esophageal Squamous Cell Carcinoma

Launched by SHANGHAI ZHONGSHAN HOSPITAL · Jul 2, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new way to personalize treatment for people with esophageal squamous cell carcinoma, a type of esophageal cancer that can be surgically removed. Researchers are using tiny, lab-grown versions of patients’ own tumors—called patient-derived organoids (PDOs)—to see if these mini tumors can predict how well a patient will respond to treatments given before surgery, such as chemotherapy and immunotherapy. The goal is to find out if testing drugs on these PDOs matches what actually happens in the patient, which could help doctors choose the best treatment plans in the future.

People eligible for this study are adults aged 18 to 75 who have been diagnosed with this specific kind of esophageal cancer that can be surgically removed. They need to be in generally good health and able to undergo standard treatment. Participants will provide small tissue samples during routine diagnostic procedures, and optionally blood samples, which will be used to grow the mini tumors and study immune responses in the lab. While patients continue with their usual care decided by their doctors, researchers will compare lab test results with how patients respond to treatment over time. Joining the study is voluntary, and all personal information will be kept confidential. This research aims to improve personalized cancer treatment by better matching therapies to individual tumor responses, potentially making treatments more effective and reducing unnecessary side effects.

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Eligibility 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).