A Randomized Phase II Clinical Trial of Nab-Paclitaxel and Carboplatin Compared With Gemcitabine and Carboplatin as First-line Therapy in Advanced Squamous Cell Carcinoma of Lung
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Overall response rate(ORR)
研究概览
简要总结
This trial is to study the efficacy of nab-PC vs. GC and evaluate toxicity of nab-PC in advanced squamous cell cancer of lung. The correlation between the efficacy of nab-PC and some biomarkers is also to be evaluated.
详细描述
Albumin-bound paclitaxel(nab-P) utilizes the albumin binding proteins,such as (gp60)/caveolin-1 (CAV1) and SPARC(secreted protein acidic and rich in cysteine), achieving high intratumoral paclitaxel accumulation. It is reported that CAV1 is overexpressed in squamous cell cancer(SQC), so it is possible that nab-PC is more highly active than GC in SQC of lung.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Previously untreated, histological documented stage IIIB (not amenable for radical regional therapy) or stage IV squamous cell carcinoma of lung. At least one measurable lesion as defined by RECIST criteria.
- •At least 18 years of age.
- •ECOG PS 0~1
- •Patients have no previously malignant tumor history except cured cervical carcinoma in situ, basal cell carcinoma or superficial bladder cancer. Patients are also eligible if they have received a chemotherapy regimen as neoadjuvant or adjuvant chemotherapy and the disease recurred over 12 months since the finishing of neoadjuvant or adjuvant chemotherapy.
- •neutrophil ≥ 1.5 x 109 /L, Hemoglobin > 90 g/L, Platelet count > 100x109/L.
- •Total bilirubin ≤ 1.5 x upper limit of normal. ALT and AST < 2.5 x upper limit of normal without liver metastasis, ALT and AST < 5 x upper limit of normal with liver metastasis. Serum creatinine < 1.5 x upper limit of normal.
- •Urine pregnancy test is negative for woman.
- •Estimated life expectancy is at least 3 months.
- •Patient comply with the clinical trial protocal.
- •Informed consent must be signed.
排除标准
- •Patients who are currently undergoing other anti-tumor therapy.
- •Patients who was enrolled in any other clinical trial within 4 weeks of study entry.
- •Any physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of any study medication or render the subject at high risk from treatment.
- •Central nervous system (CNS) tumor or metastatic tumor.
- •Serious mental disorder.
- •Serious dysgnosia.
- •Other serious comorbidity.
- •Alcohol or drug dependence.
- •Previously allergic to drugs used in the study.
研究组 & 干预措施
Albumin paclitaxel plus carboplatin
Treatment of Albumin paclitaxel plus carboplatin
干预措施: Albumin paclitaxel plus carboplatin (Drug)
Gemcitabine plus carboplatin
Treatment of Gemcitabine plus carboplatin
干预措施: Gemcitabine plus carboplatin (Drug)
结局指标
主要结局
Overall response rate(ORR)
时间窗: 18weeks
ORR is evaluated after at most 6 cycles of chemotherapy, which may cost 18 weeks.
次要结局
- Response duration, progression free survival, overall survival, safety profile(2 years)
研究者
Yi-Long Wu
Professor
Chinese Society of Lung Cancer