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Clinical Trials in China / NCT04174079
Recruiting Not applicable

Study on Adjuvant Chemotherapy After Total Two-field Lymph Node Dissection of Thoracic Esophageal Squamous Cell Carcinoma

NCT04174079 · tracked via the Priya Life Science China tracker
Sponsor
Sun Yat-Sen University Cancer Center
Phase
Not applicable
Started
2019-12-11
Last updated
2026-07-21

Condition(s) studied

Thoracic Esophageal Squamous Cell Carcinoma

Investigational drug(s) / intervention(s)

chemotherapy

chemotherapy: patients with R0 resected T≥3 or N≥1 thoracic esophageal squamous cell carcinoma began to receive chemotherapy of docetaxel combined with nedaplatin within 8 weeks after total two-field lymph node dissection. Docetaxel 75mg/m2 day 1, nedaplatin 75mg/m2 day 1, every 21 days for 4 cycles

Study summary

Patients with thoracic esophageal squamous cell carcinoma after total two-field lymph node dissection were randomized into the adjuvant chemotherapy group or the postoperative observation group

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: 1. Patients with esophageal squamous cell carcinoma who received radical surgical resection and total two-field lymph node dissection did not receive neoadjuvant therapy before surgery, and didn't suffer serious complications after surgery. 2. T≥3 or N≥1, and more than 15 lymph nodes were dissected. 3. Age ≥18 years and ≤75 years. 4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1. 5. Adequate hematological function: absolute neutrophil count (ANC) ≥ 1.5×109/L, and blood platelet count (PLT) ≥ 1.5×109/L, and hemoglobin ≥ 9g/dL. 6. Adequate hepatic function: total bilirubin ≤1.5 times the upper limit of normal (ULN), aspartate aminotransferase, alanine aminotransferase, and alkaline phosphatase ≤2.5 × ULN. 7. Adequate renal function: serum creatinine ≤1.5 × ULN and creatinine clearance ≥50 ml/min. 8. Subjects could understand and comply with study and follow-up procedures, and voluntarily signed written informed consent Exclusion Criteria: 1. Suffering from previous primary malignancy or co-existing serious illness of other organs, which will affect the judgment of the end point of this study. 2. Serious postoperative complications that will affect progress of chemotherapy. 3. Patients with chemotherapy contraindications. 4. Women who are pregnant or breast-feeding or who are planning for pregnancy. 5. Unable to complete the follow-up as planned. 6. Without informed consent due to psychological, family, social and other factors.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Sun Yat-sen Uniersity Cancer Center Guangzhou Guangdong Recruiting

More Sun Yat-Sen University Cancer Center trials in China

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04174079 on ClinicalTrials.gov ↗ ← All trials in China