NCT03964753招募中2 期
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
Hebei Medical University Fourth Hospital1 个研究点 分布在 1 个国家目标入组 202 人开始时间: 2019年4月24日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 202
- 试验地点
- 1
- 主要终点
- OS
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Neo-adjuvant chemotherapy group
Experimental
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
干预措施: Nab-paclitaxel and Cisplatin (Drug)
Neo-adjuvant chemotherapy group
Experimental
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
干预措施: surgery (Procedure)
Surgery alone
Active Comparator
Surgery alone
干预措施: surgery (Procedure)
结局指标
主要结局
OS
时间窗: up to 5 years
Overall survival，From date of randomization until death due to any cause
次要结局
- R0 resection rate(within 4 weeks following the operation)
- Rate of Operative Complications(within 4 weeks following the operation)
- DFS rate(1 year,3years,5years)
- Rate of Adverse Event(up to 6 weeks after the last dose of chemotherapy)
- OS rate(1 year,3years,5years)
- Down-staging rate(within 6 weeks following the last dose of chemotherapy)
研究者
LiuJunFeng
Director of thoracic surgery
Hebei Medical University Fourth Hospital
研究点 (1)
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