NCT07054086

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

Recruiting now Last updated 8 July 2025

What this trial tests

trial testing Neoadjuvant Chemotherapy (NACT) in Esophageal Cancer in 30 participants. Currently enrolling.

Timeline

1 March 2025

Primary endpoint
28 February 2026

31 July 2026

Quick facts

Lead sponsor	Shanghai Zhongshan Hospital
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	30
Start date	1 March 2025
Primary completion	28 February 2026
Estimated completion	31 July 2026
Sites	1 location across China

Drugs / interventions tested

• Neoadjuvant Chemotherapy (NACT) — full drug profile →

Conditions studied

• Esophageal Cancer — all drugs for Esophageal Cancer →

Sponsor

Shanghai Zhongshan Hospital

Who can join

Adults 18 to 75, any sex, with Esophageal Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Study Title:

Observing Clinical Consistency of Personalized Neoadjuvant Therapy Using Patient-Derived Organoid Models (PDO) in Resectable Esophageal Squamous Cell Carcinoma

Goal:

This study aims to explore whether patient-derived organoid models (PDO)-miniature tumors grown from patients' tissue samples-can accurately predict how individuals respond to personalized pre-surgery treatments (neoadjuvant therapy) for esophageal squamous cell cancer (ESCC). The study will compare results from drug sensitivity tests performed on PDO models with actual clinical outcomes after treatment to assess consistency and potential as a predictive tool.

Main Questions Addressed:

Do PDO models accurately reflect patients' tumor characteristics and response patterns to chemotherapy/immunotherapy combinations? Can PDO drug sensitivity testing reliably predict clinical responses (treatment effectiveness) in patients receiving personalized neoadjuvant therapy?

Study Design:

This observational study will enroll patients diagnosed with resectable ESCC who undergo standard neoadjuvant therapy (chemotherapy +/- immunotherapy) before surgery. No treatments will be assigned by the study-therapy decisions remain in physicians' discretion based on standard care protocols.

Participant Procedures:

Patients will provide tissue samples (via endoscopy) used to grow PDO models and blood samples (optional) to study immune cell interactions with tumors. These samples will enable labs to test drug responses in vitro ("lab-on-a-chip" models) while patients proceed with their standard-of-care treatments and surgeries.

Key Activities:

Lab Work (non-invasive procedures post-endoscopy/surgery):

PDO models grown from tumor tissue samples (culturing process) will mimic patients' tumors in miniature (preserving biological features).

Drug sensitivity testing (chemotherapy agents like paclitaxel, platinum drugs and immunotherapies targeting PD-1/PD-L1 pathways\*\*) will assess how tumors respond (growth inhibition rates).

Immune cell interactions (from blood samples) will model tumor-immune microenvironment responses to treatments (immunotherapy relevance).

Clinical Follow-Up:

Patients will undergo standard-of-care treatments (therapy decisions made independently) and regular monitoring post-treatment (survival follow-up every 3 months, adverse events tracked during therapy, clinical response evaluated per RECIST criteria).

Duration:

Study participation involves tissue/blood sample collection (during standard diagnostic procedures) followed by routine clinical care monitoring (treatment duration, post-surgery follow-up). Total study timeline spans March-December 2025 (1 year) with participant recruitment beginning February 2025.

Ethical Considerations:

Participants provide informed consent acknowledging optional blood sample collection (if needed) and understand study aims.

Patient identifiers removed from samples/test results ensuring confidentiality (ethical compliance).

No financial or treatment incentives-participation voluntary (patients retain autonomy) including withdrawal at any time (without affecting clinical care decisions).

Study Significance:

By bridging lab models with real-world treatment responses (PDOs validated against clinical outcomes), this research aims to develop personalized treatment strategies (precision oncology) reducing trial-and-error prescribing patterns (currently observed discrepancies in neo-adjuvant therapy responses among ESCC patients).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. The application of organoids in treatment decision-making for digestive system cancers: progress and challenges.
   Wang Y, Zhang L, Wang LZ, Cao Y, et al · · 2025 · cited 4× · PMID 40855314 · DOI 10.1186/s12943-025-02429-0