Esophageal carcinoma
Conditions
Interventions
Sponsors
Eligibility
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
| Measure | Time frame |
|---|---|
| 2-year recurrence-free survival rate, RFS;Progression Free Survival, PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Event Free Survival, EFS; | — |
Countries
China
Contacts
Department of Thoracic Surgery, First Affiliated Hospital of Xi’an Jiaotong University