Esophageal CancerNCT07054086
Patient Derived Organoids (PDOs) to Observe the Clinical Consistency of Personalized Neoadjuvant Therapy for Resectable Esophageal Squamous Cell Carcinoma
An observational study of Esophageal Cancer, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- Neoadjuvant Chemotherapy (NACT)
- Type of treatment
- Injection or infusion
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2025to 31 Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of patients diagnosed with resectable esophageal squamous cell carcinoma (ESCC) who are enrolled from Zhongshan Hospital affiliated with Fudan University. Participants must undergo endoscopic biopsy confirmation of ESCC and preoperative clinical staging via imaging modalities (e.g., CT, PET/CT). Patients aged 18-75 years with an ECOG performance status of 0-1 and adequate organ function are eligible. The study aims to evaluate the clinical consistency between PDO-derived drug sensitivity testing and actual therapeutic responses in patients undergoing neoadjuvant therapy followed by surgical resection of ESCC tumors located in the thoracic segment (upper, middle, or lower third).
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032
Ethics Review Committee of Zhongshan Hospital, Fudan Univ., 8602131587871, ec@zs-hospital.sh.cn
Lijie Tan, M.D.
About this study
Study Title:
Observing Clinical Consistency of Personalized Neoadjuvant Therapy Using Patient-Derived Organoid Models (PDO) in Resectable Esophageal Squamous Cell Carcinoma
Read more
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
- Being tested
- Neoadjuvant Chemotherapy (NACT)
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neoadjuvant Chemotherapy (NACT)Drug
The planned regimen for neoadjuvant therapy may include one or more of the following agents:
- Paclitaxel Injection
- Albumin-bound paclitaxel Injection (Abraxane® equivalent formulation)
- Cisplatin Injection
- Carboplatin Injection
- Nivolumab
- Pembrolizumab
- Toripalimab
- Tirilibumab
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Case-group | Not described Receives: Drug: Neoadjuvant Chemotherapy (NACT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Organoid Culture Success Metrics
Assessment of the success rate in establishing patient-derived organoids (PDOs) from esophageal squamous cell carcinoma tissue samples, confirmed histologically and genomically consistent with tumor tissue.
Measured: before NACT accomplishment
Secondary outcomes (2)
Clinical Efficacy Evaluation
Quantitative assessment of tumor response to neoadjuvant therapy using criteria from RECIST version 1.1 criteria (Complete Response [CR], Partial Response [PR], Stable Disease [SD], Progressive Disease [PD]).
Measured: 4-6 weeks after NACT complete
Drug Sensitivity Concordance
Evaluation of consistency between in vitro drug sensitivity results from PDO models and clinical tumor response following neoadjuvant therapy. Key parameter: Maximum percent inhibition rate of tumor organoids exposed to programmed drug regimens (e.g., paclitaxel, pembrolizumab combinations).
Measured: before NACT treatment accomplishment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2025
- Study start1 Mar 2025
- Primary completion28 Feb 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Accurate International Biotechnology (Guangzhou) Co., Ltd.
- Responsible party
- Principal investigator, Tan Lijie, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07054086
- Sponsor's protocol ID
- B2024-594R
- Status last verified
- Jul 2025
- First submitted
- 25 May 2025
- Last updated
- 8 Jul 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Derived Organoids (PDOs) to Observe the Clinical Consistency of Personalized Neoadjuvant Therapy for Resectable Esophageal Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT07054086
- Acronym / sponsor ID
- B2024-594R
- Conditions
- Esophageal Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Collaborators
- Accurate International Biotechnology (Guangzhou) Co., Ltd.
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 28 Feb 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 8 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Case-group | – | Drug: Neoadjuvant Chemotherapy (NACT) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of patients diagnosed with resectable esophageal squamous cell carcinoma (ESCC) who are enrolled from Zhongshan Hospital affiliated with Fudan University. Participants must undergo endoscopic biopsy confirmation of ESCC and preoperative clinical staging via imaging modalities (e.g., CT, PET/CT). Patients aged 18-75 years with an ECOG performance status of 0-1 and adequate organ function are eligible. The study aims to evaluate the clinical consistency between PDO-derived drug sensitivity testing and actual therapeutic responses in patients undergoing neoadjuvant therapy followed by surgical resection of ESCC tumors located in the thoracic segment (upper, middle, or lower third).
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Case-group |
Primary outcome
Organoid Culture Success Metrics
Time frame: before NACT accomplishment
Assessment of the success rate in establishing patient-derived organoids (PDOs) from esophageal squamous cell carcinoma tissue samples, confirmed histologically and genomically consistent with tumor tissue.
2 secondary outcomes
Clinical Efficacy Evaluation
Time frame: 4-6 weeks after NACT complete
Drug Sensitivity Concordance
Time frame: before NACT treatment accomplishment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophageal Cancer, run by Shanghai Zhongshan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Organoid Culture Success Metrics (time frame: before NACT accomplishment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2025.