Phase II Study of Albumin Bound Paclitaxel Plus S-1 as the First Line Chemotherapy in Advanced or Recurrent Gastric Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 73
- 试验地点
- 1
- 主要终点
- Progression-free survival
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness and safety of s-1 plus Albumin Bound Paclitaxel as first-line therapy in the treatment of patients with advanced gastric cancer.
详细描述
As the first phase II clinical trial of fluoropyrimidines plus Nab-PTX in AGC patientsphase II trial, this study aimed to evaluate the efficacy and safety of S-1 plus Nab-PTX as a first-line treatment for patients with metastatic gastric cancer. All patients were orally treated with S-1 in doses of 40 mg (BSA<1.25 m2), 50 mg (1.25≤BSA<1.50 m2) and 60 mg (BSA≥1.50 m2) b.i.d. on days 1-14 in combination with Nab-PTX (240 mg/m2, divided on days 1 and 8, intravenously for 30 minutes) of each 21-day cycle. Treatment was planned for 6 cycles or until progression, unacceptable toxicity, or patient refusal.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed adenocarcinoma of the stomach with inoperable locally advanced or recurrent and/or metastatic disease.
- •Male or female.
- •No previous chemotherapy for advanced/metastatic disease (prior adjuvant/neoadjuvant therapy is allowed if at least 6 months has elapsed between completion of adjuvant/neoadjuvant therapy and enrolment into the study).
- •Measurable disease, according to the Response Evaluation Criteria in Solid Tumours(RECIST)
- •ECOG Performance status 0, 1 or 2
- •Haematological, Biochemical and Organ Function: Neutrophil count >2.0 × 10 9/L, platelet count > 100 ×10 9/L. Serum bilirubin< 1.5 × upper limit of normal (ULN); or, AST or ALT < 2.5 × ULN (or < 5 × ULN in patients with liver metastases); or, alkaline phosphatase< 2.5 × ULN (or > 5 × ULN in patients with liver metastases,Creatinine clearance > 60 mL/min.
- •Signed informed consent.
排除标准
- •Prior palliative chemotherapy.
- •Received any investigational drug treatment within 30 days of start of study treatment.
- •Patients with active gastrointestinal bleeding.
- •Other malignancy within the last 5 years, except for carcinoma in situ of the cervix, or basal cell carcinoma.
- •History or clinical evidence of brain metastases.
- •Serious uncontrolled systemic intercurrent illness, e.g. infections or poorly controlled diabetes.
- •Pregnancy women.
- •Subjects with reproductive potential not willing to use an effective method of contraception.
- •Patients with known active infection with HIV.
- •Known hypersensitivity to any of the study drugs.
- •Neurological toxicity ≥ grade 2 NCI-CTCAE.
研究组 & 干预措施
Albumin Bound Paclitaxel plus S-1
Abraxane 120 mg/m2, D1,D8;S-1 40~60mg QD D1-D14,every 3 weeks until disease progress or intolerable toxicity.
干预措施: Albumin Bound Paclitaxel (Drug)
Albumin Bound Paclitaxel plus S-1
Abraxane 120 mg/m2, D1,D8;S-1 40~60mg QD D1-D14,every 3 weeks until disease progress or intolerable toxicity.
干预措施: S-1 (Drug)
结局指标
主要结局
Progression-free survival
时间窗: through study completion, an average of 2 years
Progression-free survival is determined from the date of treatment to PD or death.
次要结局
- Overall survival(OS follow-up period: 18 months or 80% OS events, whichever occurs first.)
- Response rate(up to one year)
- Disease control rate(AEs (Adverse events) should be recorded during the study period and six months after last IMP administration)
研究者
Ruihua Xu
Professor of Medical Oncology,Vice-president of Sun Yat-sen University Cancer Center
Sun Yat-sen University