Jun Feng Liu
Shijiazhuang, Hebei, 050011, China
Location status: Recruiting
NCT Number: NCT03964753
To verify the role of nab-paclitaxel in neoadjuvant therapy for esophageal squamous cell carcinoma, the investigators designed a prospective, randomized, controlled , multicente phase II trial, to investigate the efficacy and safety of nab-paclitaxel combined with cisplatin as neoadjuvant therapy followed by surgery versus surgery alone for esophageal squamous cell carcinoma.
Interested in participating?
Request Info18 year–75 year
All sexes
Interventional
Phase 2
Shijiazhuang, Hebei, 050011, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Bone marrow function: neutrophils ≥ 1.5×10(9)/L, platelets ≥ 100×10(9)/L, hemoglobin ≥ 90 g/L Liver function:Total bilirubin ≤ 1.5x ULN;AST and ALT) ≤ 2.5x ULN Renal function:Cr ≤ 1.5x ULN,Ccr ≥ 55 ml/min Coagulation function:INR≤1.5×ULN, PT≤1.5ULN, APTT within the normal range
Exclusion criteria
Nab-paclitaxel,125mg/m(2), d1,d8, Cisplatin,75mg/m(2), d1, 3 week, 2 cycles.
surgery
Time frame: up to 5 years
Overall survival,From date of randomization until death due to any cause
Time frame: 1 year,3years,5years
Overall survival rate
Time frame: 1 year,3years,5years
Disease free survival rate
Time frame: within 4 weeks following the operation
R0 resection rate
Time frame: within 6 weeks following the last dose of chemotherapy
Down-staging rate
Time frame: within 4 weeks following the operation
Time frame: up to 6 weeks after the last dose of chemotherapy
Incidence of adverse events according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03
Contact information is provided by the study sponsor or research team.
Hebei Medical University Fourth Hospital
Other
The Effectiveness and Safety of Neoadjuvant Therapy With Nab-paclitaxel and Cisplatin Followed by Surgery Versus Surgery Alone for Locally Advanced Esophageal Squamous Cell Carcinoma
Acronym: NTNC
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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