neoadjuvant therapy with nab-paclitaxel and cisplatin for locally advanced esophageal squamous cell carcinoma

Conditions: Esophageal Squamous Cell Carcinoma

Summary: 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.


Eligibility criteria:
inclusion criteria: * age ranges from 18 to 75 years * radiographically, histologically or/and cytologically diagnosed resectable locally advanced middle-lower esophageal squamous cell carcinoma without distant metastasis,ct1n1m0 or t2-3n0-1m0(according to uicc esophageal cancer tnm staging system 8th edition) * enhanced ct showed the presence of potentially resectable lesions. resectability features included no evidence of mediastinal infiltration, no evidence of tracheobronchial fistula or tumor entry into the airway * have not previously received systemic antitumor therapy for esophageal squamous cell carcinoma (including radiotherapy, chemotherapy, targeted therapy, immunotherapy) * ecog performance status 0-1 * expected survival more than 6 months * no contraindications in the organ function tests before surgery * the laboratory test meet the following requirements: 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 * female patients of child-bearing age agree to take effective contraceptive measures during the study period and 6 months after reseach completion；pregnancy tests in serum or urine must be negative 7 days prior to study enrollment；non-lactating patients；male patients agree to take effective contraceptive measures during the study period and 6 months after reseach completion * not concomitant with other uncontrollable benign disease before the recruitment(e.g. the infection in the kidney, lung and liver) * not participating in other clinical trials 4 weeks before the treatment * the patient has good compliance with the planned treatment, understands the research process of the study and signs a written informed consent form. exclusion criteria: * histological confirmation of esophageal adenocarcinoma * with distant metastasis, without radical resection (stage iv) * ever administrated with other drugs(including tcm drugs) before the recruitment, or no guarantee of progress according to the study requirement after recruitment * grade 2 or above peripheral neuropathy or hemorrhage according to nci ctcae 4.03 * combined with severe cardiovascular disease, including hypertension that cannot be controlled by medical treatment(bp≥160/95mmhg), unstable angina, a history of myocardial infarction in the past 6 months,congestive heart failure\>nyha grade ii, severe arrhythmia, pericardial effusion, etc. * combined with severe adh abnormal secretion syndrome, poorly controlled diabetes: more than 40 units of insulin per day need to be continuously administered; or 40 units of insulin per day for continuous use or not used, but fasting blood glucose is still above 14mmol / l, hba1c above 9.0 * long-term use of anticoagulants or vitamin k antagonists such as warfarin, heparin or its analogues for more than 6 months,small doses of warfarin (≤1mg / day) or aspirin (≤100mg / day) for prevention purposes are not included * major surgery within 4 weeks prior to enrollment, or surgical wounds have not fully healed * operation can not use the stomach instead of esophageal cancer to reconstruct the digestive tract due to previous operation * severe infection within 1 week prior to the start of study, requiring intravenous antibiotics, antifungal or antiviral therapy * known to be allergic, highly sensitive or intolerable to research-related drugs or excipient * in the past 5 years, there were other malignant tumors, melanoma skin cancer or ervical carcinoma in situ were excepted * any indicator shows chemotherapy and surgery contraindications * women who are pregnant or lactating * the investigator determined that unable to complete the study due to medical, social, or psychological reasons or were unable to sign valid informed consent