Neoadjuvant Therapy With Nab-paclitaxel and Cisplatin for Locally Advanced Esophageal Squamous Cell Carcinoma

Официальное название

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

Обзор

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.

Вмешательства

• Препарат Nab-paclitaxel and Cisplatin
  Nab-paclitaxel,125mg/m(2), d1,d8, Cisplatin,75mg/m(2), d1, 3 week, 2 cycles.
• Процедура surgery
  surgery

Первичные конечные точки

• OS [Срок оценки: up to 5 years]

Вторичные конечные точки (6)

• OS rate [Срок оценки: 1 year,3years,5years]
• DFS rate [Срок оценки: 1 year,3years,5years]
• R0 resection rate [Срок оценки: within 4 weeks following the operation]
• Down-staging rate [Срок оценки: within 6 weeks following the last dose of chemotherapy]
• Rate of Operative Complications [Срок оценки: within 4 weeks following the operation]
• Rate of Adverse Event [Срок оценки: up to 6 weeks after the last dose of chemotherapy]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Jun Feng Liu — Shijiazhuang

Идентификаторы

NCT: NCT03964753 · HebeiJLiu

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗