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

NCT07054086 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2025-07-08

No results posted yet for this study

Summary

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).

Conditions

  • Esophageal Cancer

Interventions

DRUG

Neoadjuvant Chemotherapy (NACT)

The planned regimen for neoadjuvant therapy may include one or more of the following agents: 1. Paclitaxel Injection 2. Albumin-bound paclitaxel Injection (Abraxane® equivalent formulation) 3. Cisplatin Injection 4. Carboplatin Injection 5. Nivolumab 6. Pembrolizumab 7. Toripalimab 8. Tirilibumab 9. Camrelizumab The specific agent(s) and their combination will be selected based on the patient's clinical treatment protocol. The final regimen must be approved jointly by the principal investigator and the attending physician according to established clinical guidelines and individualized patient factors.

Sponsors & Collaborators

  • Accurate International Biotechnology (Guangzhou) Co., Ltd.

    collaborator UNKNOWN

  • Shanghai Zhongshan Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-01
Primary Completion
2026-02-28
Completion
2026-07-31
FDA Drug
Yes

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07054086 on ClinicalTrials.gov