Neoadjuvant Therapy With Nab-paclitaxel and Cisplatin for Locally Advanced Esophageal Squamous Cell Carcinoma
Phase 2
Recruiting
- Conditions
- Esophageal Squamous Cell Carcinoma
- Interventions
- Drug: Nab-paclitaxel and CisplatinProcedure: surgery
- Registration Number
- NCT03964753
- Lead Sponsor
- Hebei Medical University Fourth Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 202
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Neo-adjuvant chemotherapy group surgery cisplatin and nab-paclitaxel: Nab-paclitaxel, 125mg/m(2), d1,d8, Cisplatin, 75mg/m(2), d1, 3 week, 2 cycles. Surgery: 4-6weeks after Neo-adjuvant chemotherapy Neo-adjuvant chemotherapy group Nab-paclitaxel and Cisplatin cisplatin and nab-paclitaxel: Nab-paclitaxel, 125mg/m(2), d1,d8, Cisplatin, 75mg/m(2), d1, 3 week, 2 cycles. Surgery: 4-6weeks after Neo-adjuvant chemotherapy Surgery alone surgery Surgery alone
- Primary Outcome Measures
Name Time Method OS up to 5 years Overall survival，From date of randomization until death due to any cause
- Secondary Outcome Measures
Name Time Method R0 resection rate within 4 weeks following the operation R0 resection rate
Rate of Operative Complications within 4 weeks following the operation DFS rate 1 year,3years,5years Disease free survival rate
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
OS rate 1 year,3years,5years Overall survival rate
Down-staging rate within 6 weeks following the last dose of chemotherapy Down-staging rate
Trial Locations
- Locations (1)
Jun Feng Liu
🇨🇳Shijiazhuang, Hebei, China