NCT01796782Unknown2 期
A Prospective, Randomized, Open-label, Phase II Study of QYHJ Granules Versus Xeloda in the Second-line Treatment of Patients With Metastatic Pancreatic Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 60
- 主要终点
- overall survival (OS)
研究概览
简要总结
Primary End Point:
- To compare the overall survival (OS) using QYHJ Granules or Xeloda as the second therapy in patients with metastatic pancreatic cancer.
Secondary End Points:
- Compare clinical efficacy by other measures including PFS,tumor response,and changes in quality of life (QOL) between these two groups.
- Examine the feasibility and assess the side effects of treatment using QYHJ Granules in patients with metastatic pancreatic cancer.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically/cytologically confirmed metastatic pancreatic adenocarcinoma.
- •Patients have failed from the prior chemotherapy without Xeloda. Adjuvant chemotherapy containing Xeloda and 6 months before recruitment is included.
- •Patients haven't taken QYHJ Granules before. Prior exposure to Traditional Chinese Medicine not based on QYHJ Formula is allowed provided that at least one week washout time is given prior to initiation of experimental treatment.
- •ECOG performance status 0, 1 or
- •Measurable disease by RECIST criteria must be present. Bone scan abnormalities alone will not be accepted as measurable disease. Lytic lesions seen on plain radiographs will not be accepted as measurable disease but will be evaluated in conjunction with bone scan abnormalities. Pure blastic bone metastases will not be accepted as measurable disease. Pleural or peritoneal effusions will not be accepted as measurable disease. Irradiated lesions are not considered measurable.
- •Patients must not be pregnant. Serum beta-HCG will be checked in all premenopausal patients.
- •Patients must have adequate organ functions reflected by the laboratory criteria below: neutrophil counts ≥ 1.5×109 /L, platelet count ≥ 100 x 109/L, hemoglobin ≥ 85 g/L, Serum creatinine < 2.0 mg/dL, Bilirubin < 1.5 mg/dL, ALT < 3 x normal, albumin >30g/L.
- •Prior local therapy, e.g., TACE or radiation, is allowed provided that at least 4 weeks washout time is given.
- •Concomitant bisphosphonates are allowed for patients with bone metastases. Patients with jaundice must have a biliary drainage decompression operation before recruitment.
- •Ability to understand and the willingness to sign a written informed consent.
- •Subjects who have a life expectancy of at least 3 months.
排除标准
- •ECOG performance status 3 or
- •Known central nervous system involvement and leptomeningeal disease.
- •Previous Xeloda-based chemotherapy （except usage for Adjuvant chemotherapy and 6 months before recruitment）.
- •Prior treatment with QYHJ Granules.
- •Other serious illness or condition including cardiac disease including congestive heart failure (New York Heart Association Classification III or IV),unstable angina, myocardial infarction within the past six months, severe arrhythmia.
- •Concurrent infection requiring intravenous antibiotics, active HIV infection/HIV disease, psychiatric disorders, drug abuse.
- •Known allergies to the QYHJ or Xeloda.
- •Pregnant or lactating females. Serum pregnancy test to be assessed within 7 days prior to study treatment start, or within 14 days with a confirmatory urine pregnancy test within 7 days prior to study treatment start. Men and women of childbearing potential not using effective means of contraception.
- •Known other non-adenocarcinoma pathological type.
- •Other primary tumour (including primary brain tumours) within the last 5 years prior to enrollment, except for adequately treated carcinoma in situ of the cervix or basal cell skin cancer.
- •Inability to take oral medication, prior surgical procedures affecting absorption or unwilling to take the Traditional Chinese Medicine.
- •Patiens who are suffering from diarrhea.
- •Subjects with poor compliance.
研究组 & 干预措施
Xeloda
Active Comparator
Subjects will receive Xeloda until progression
干预措施: Xeloda (Drug)
QYHJ Granules
Experimental
patients will receive QYHJ Granules until progression
干预措施: QYHJ Granules (Drug)
结局指标
主要结局
overall survival (OS)
时间窗: up to 3 years
次要结局
- Progression free survival（PFS）(up to 3 years)
- Tumor response（ORR、DCR）(up to 3 years)
- Clinical benefit rate （CBR）and QOL assessment(up to 3 years)
- Number of adverse events of QYHJ Formula(up to 3 years)
研究者
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