Esophageal Squamous Cell Carcinoma
Conditions
Brief 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.
Interventions
DRUGNab-paclitaxel and Cisplatin
Nab-paclitaxel,125mg/m(2), d1,d8, Cisplatin,75mg/m(2), d1, 3 week, 2 cycles.
PROCEDUREsurgery
surgery
Sponsors
Hebei Medical University Fourth Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| OS | up to 5 years | Overall survival，From date of randomization until death due to any cause |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| DFS rate | 1 year,3years,5years | Disease free survival rate |
| R0 resection rate | within 4 weeks following the operation | R0 resection rate |
| OS rate | 1 year,3years,5years | Overall survival rate |
| Rate of Operative Complications | within 4 weeks following the operation | — |
| Rate of Adverse Event | 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 |
| Down-staging rate | within 6 weeks following the last dose of chemotherapy | Down-staging rate |
Countries
China
Contacts
Primary ContactJunfeng Liu, PhD
Outcome results
None listed