Overview

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

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