NCT04047953招募中不适用
The Study of Paclitaxel (Albumin-bound) Combined With Oxaliplatin and S-1 Conversion Therapy for Initial Unresectable Local Advanced or Potentially Resectable Metastatic Gastric Adenocarcinoma
Peking University Cancer Hospital & Institute1 个研究点 分布在 1 个国家目标入组 95 人开始时间: 2019年9月10日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 95
- 试验地点
- 1
- 主要终点
- R0 resection rate
研究概览
简要总结
To evaluate the efficacy and safety of Paclitaxel (albumin-bound) combined with Oxaliplatin and S-1 conversion therapy for initial unresectable local progression or potential resectable metastatic gastric adenocarcinoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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 of 18-75 years; male or female.
- •Karnofsky Performance Status Score ≥
- •Histological diagnosis of gastric adenocarcinoma, HER2 expression negative.
- •The initial unresectable locally advanced or potentially resectable metastatic gastric adenocarcinoma, potentially resectable factor includes a single liver metastases, localized abdominal para-aortic lymph node (16a1 / b2) metastasis or positive abdominal free cancer cells.
- •Physical condition and organ function allow for larger abdominal surgery.
- •Subject baseline blood routine and blood biochemistry indexes meet the following criteria: hemoglobin(HB) ≥90 g/L; absolute neutrophil count(ANC) ≥1.5×109 /L; platelet count(PLT) ≥100×109 /L; alanine glutamate transaminase (ALT) and glutamate transaminase (AST) ≤2.5 x upper limit of normal range (ULN); total bilirubin (TBIL)≤1.5 x upper limit of normal range (ULN); Creatinine(Cr)≤1.5 x upper limit of normal range(ULN); Serum albumin≥30g/L.
- •Echocardiographic scan confirmed left ventricular ejection fraction (LVEF) ≥ 50%.
- •No serious accompanying disease lead to a survival period of <5 years.
- •Agree and be able to follow the protocol during the study period.
- •Written informed consent was provided prior to the study screening and the patient was informed that the study could be withdrawn at any time during the study without any loss.
排除标准
- •For the treatment of the gastric cancer, patients who have received cytotoxic chemotherapy, radiotherapy or immunotherapy, except corticosteroids.
- •Pregnancy or breastfeeding woman.
- •Women of childbearing age who had a positive pregnancy test at baseline or who did not undergo a pregnancy test. Menopausal women must be stopped for at least 12 months to ensure that no pregnancy is possible.
- •Men and women who have sex (with fertility probability) are reluctant to contraception during the study.
- •Patients with ascites and positive abdominal free cancer cells.
- •There are other history of malignant disease in the last 5 years, except for cured skin cancer and cervical carcinoma in situ.
- •Those with a history of epilepsy, central nervous system disease, or mental disorder may be judged by the investigator that their clinical severity may hinder the signing of informed consent or affect the patient's oral medication compliance.
- •Clinically severe (active) heart disease, such as symptomatic coronary heart disease, New York Heart Association (NYHA) class II or more severe congestive heart failure or severe drug-affected arrhythmias, or there is a history of myocardial infarction in the last 12 months.
- •Upper gastrointestinal stagnation or abnormal physiological function or malabsorption syndrome may affect the absorption of S-
- •It is known to have peripheral neuropathy ≥ NCI CTC AE grade
- •However, only the deep sputum reflex (DTR) disappears and the patient does not have to be excluded.
- •Organ transplantation requires immunosuppressive therapy.
- •Severe uncontrolled recurrent infections, or other serious uncontrolled concomitant diseases.
- •Moderate or severe renal impairment [creatinine clearance equal to or lower than 50ml/min (calculated according to Cockcroft and Gault equations), or serum creatinine > upper normal limit (ULN).
- •Those suffering from dihydropyrimidine dehydrogenase (DPD) deficiency are known.
- •Those who are allergic to taxanes or any research ingredients.
- •Those who received research medications or preparations/treatments (ie, participated in other trials) within 4 weeks prior to enrollment.
研究组 & 干预措施
Conversion Therapy
Experimental
Paclitaxel (albumin-bound) +S-1+Oxaliplatin
干预措施: Paclitaxel (albumin-bound) combined with Oxaliplatin and S-1 (Drug)
结局指标
主要结局
R0 resection rate
时间窗: within 4 weeks following the operation
Proportion of patients who achieved R0 resection
次要结局
- overall survival (OS)(5 years)
- Adverse Events(AEs)(until 28 days after the last study drug administration)
- Progression free survival (PFS)(5 years)
研究者
Zhaode Bu
Clinical Professor
Peking University Cancer Hospital & Institute
研究点 (1)
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