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Clinical Study of 3D Organoid Drug Sensitivity Testing to Guide Individualized Treatment for Resectable Esophageal Cancer Patients

Clinical Study of 3D Organoid Drug Sensitivity Testing to Guide Individualized Treatment for Resectable Esophageal Cancer Patients

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500102227
Enrollment
Unknown
Registered
2025-05-12
Start date
2025-06-01
Completion date
Unknown
Last updated
2025-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal carcinoma

Interventions

Experimental group:Constructing esophageal cancer organoid models for chemotherapeutic drug sensitivity testing to guide individualized adjuvant chemotherapy regimens af
Control group:Utilizing the standard adjuvant chemotherapy regimen after surgery (TP).

Sponsors

First Affiliated Hospital of Xi’an Jiaotong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: 1. Age 18 to 75 years, regardless of gender; 2. Patients diagnosed with esophageal cancer, without contraindications for surgery, no neoadjuvant treatment received, and undergoing radical esophagectomy (R0 resection); 3. Postoperative pathological confirmation of tumor stage as pT2N0 with pathological high-risk factors (lymphovascular invasion, intravascular tumor thrombus, poorly differentiated) / pT1-4aN+ / pT3-4aN-, and patients who require adjuvant chemotherapy after surgery; 4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1; 5. General condition is acceptable, with no contraindications for systemic chemotherapy. 6. Before the study, voluntary informed consent is signed, and the patient and/or their legal guardian are capable of fully understanding the content, process, and potential adverse reactions of the trial, and are able to ensure that the patient complies with the visit schedule as specified in the protocol.

Exclusion criteria

Exclusion criteria: Exclusion criteria: 1. Postoperative pathological type is adenocarcinoma or other histological subtypes other than squamous cell carcinoma; 2. Patients with recurrent or secondary esophageal cancer; 3. Presence of multiple tumors; 4. Presence of distant metastasis (pM1); 5. Patients who develop severe complications or comorbidities postoperatively that make them unsuitable for adjuvant chemotherapy; 6. Poor function of vital organs, unable to tolerate chemotherapy; 7. Patients with psychological, psychiatric, or neurological disorders; 8. Patients with cachexia or severe malnutrition, with an estimated survival of less than 6 months; 9. Presence of other comorbidities or concomitant medications that, in the investigator's judgment, may affect the outcomes of this study. 10. Patients who are simultaneously participating in another clinical study, or others deemed unsuitable for participation in this clinical trial by the investigator.

Design outcomes

Primary

MeasureTime frame
2-year recurrence-free survival rate, RFS;Progression Free Survival, PFS;

Secondary

MeasureTime frame
Event Free Survival, EFS;

Countries

China

Contacts

Public ContactZhuoqi Jia

Department of Thoracic Surgery, First Affiliated Hospital of Xi’an Jiaotong University

gosnow@163.com+86 29 8532 3920

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026