Esophageal cancer
Conditions
Interventions
Intervention group:Endoscopic Resection Combined with Adjuvant Chemoradiotherapy
Sponsors
Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-80 years, ECOG PS score 10 mm in short axis on EUS or CT. Suspected metastatic lymph nodes must be further excluded by PET-CT or pathological biopsy. Additional investigations (brain MRI, bone scan, or PET-CT) may be performed if metastatic symptoms are suspected. 3. Primary lesion located in the thoracic esophagus and assessed by endoscopic experts to be completely resectable. 4. Preoperative clinical stage: cT1bN0M0. 5. Histopathological confirmation of esophageal squamous cell carcinoma by endoscopic biopsy. 6. Not pregnant and no pregnancy planned within the next 12 months (urine or serum pregnancy test required for women of childbearing potential). 7. No severe medical comorbidities or major organ dysfunction; normal hematologic, hepatic, renal, and cardiac function. 8. Willing and able to comply with treatment, follow-up, and pathological examinations per protocol, and capable of providing written informed consent.
Exclusion criteria
Exclusion criteria: 1. Presence of other untreated or incurable malignancies. 2. Allergy to platinum-based drugs or paclitaxel. 3. Inability or refusal to undergo endoscopic therapy, or contraindications to radiotherapy due to other reasons. 4. Esophageal stenosis preventing the passage of a gastroscope. 5. Prior esophageal ablation therapies (including photodynamic therapy, multipolar electrocoagulation, argon plasma coagulation, laser therapy, or other treatments) or thoracic radiotherapy. 6. Previous esophageal surgery (excluding uncomplicated fundoplication, e.g., without slippage or dysphagia). 7. Uncontrolled coagulation dysfunction: INR > 2 or platelet count < 75,000/µL. 8. Current use of aspirin, clopidogrel, or other NSAIDs that cannot be discontinued 7 days before and after the treatment period. 9. Uncontrolled drug or alcohol dependence impairing the ability to understand or comply with medical instructions, including informed consent, treatment protocols, or follow-up guidelines. 10. Implantable pacemaker devices (e.g., AICD, neurostimulator, cardiac pacemaker) without approval from the specialist managing the device for study participation. 11. Psychiatric disorders, severe medical conditions, or major organ dysfunction. 12. Pregnancy, lactation, or unwillingness to use contraception (if applicable). 13. Inability to comprehend or provide informed consent. 14. Investigator’s judgment that the patient is unsuitable for the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3-year overall survival;Toxicity ; | — |
Secondary
| Measure | Time frame |
|---|---|
| 3-year disease-free survival;3-year local recurrence-free survival;3-year distant metastasis-free survival;local control rate;distant metastasis rate;quality of life; | — |
Countries
China
Contacts
Public ContactZhouguang Hui
Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Outcome results
None listed