NCT00805896Unknown2 期
Effectiveness and Safety Study of TACE Plus Oral Songyou Granule for Unresectable HCC
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 260
- 试验地点
- 2
- 主要终点
- Time to tumor progression(TTP)
研究概览
简要总结
Songyou Granule is a mixture of 6 herbs. Vitro and vivo studies showed that Songyou Granule can inhibit HCC cells grow, and HCC metastasis. Hypothesis of this study is that TACE plus Songyou Granule will improve outcome in patients with advanced hepatocellular carcinoma (HCC) compared with TACE.
详细描述
Primary outcome Measures:
To evaluate the effect of TACE plus Songyou Granule or TACE plus placebo on TTP
Secondary Outcome Measures:
- Overall survival (OS)
- Progression Free Survival (PFS)
- The overall response rate
- Time to symptomatic Progression
- In an exploratory manner the relative TTP, TTSP, RR and overall survival between the 2 study populations
- Overall response duration and time to objective response
- Overall disease control rate
- The safety, tolerability, and adverse event profiles of the two treatment regimens used in this trial
Enrollment: 260 Study Start Date: January 2009 Study Completion Date: December 2010 Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
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
- Triple (Participant, Care Provider, Investigator)
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
- •Adults patients (≥ 18 years of age) with a diagnosis of HCC which is not amenable to surgical resection or local ablative therapy
- •Histological confirmed HCC or clinical/laboratory diagnosis of HCC or nodules larger than 2 cm with typical vascular features or AFP > 200
- •Patient must have quantifiable disease limited to the liver
- •Patients must have at least one tumor lesion that meets both of the following criteria:
- •The lesion can be accurately measured in at least one dimension according to RECIST criteria
- •The lesion has not been previously treated with surgery, radiation therapy, radiofrequency ablation, percutaneous ethanol or acetic acid injection, or cryoablation.
- •ECOG performance status (PS) <2
- •No prior targeted antiangiogenic therapy. Metronomic chemotherapies are allowed. At least 4 weeks since prior systemic chemotherapy
- •No significant baseline liver dysfunction. Cirrhotic status of Child-Pugh class A or B
- •No significant renal impairment (creatinine clearance < 30 mL/minute) or patients on dialysis
- •The following laboratory parameters:
- •Platelet count ≥ 50,000/µL
- •Hemoglobin ≥ 8.5 g/dL
- •Total bilirubin ≤ 2 mg/dL
- •ASL and AST ≤ 5 x upper limit of normal
- •Serum creatinine ≤ 1.5 x upper limit of normal
- •INR ≤ 1.5 or a PTT within normal limits
- •Ability to understand the protocol and to agree to and sign a written informed consent document
排除标准
- •Previous or concurrent cancer that is distinct in primary site or histology from HCC except cervical carcinoma in situ, treated basal-cell carcinoma of the skin, superficial bladder tumors (Ta, Tis & T1), and any cancer curatively treated > 3 years prior to entry is permitted
- •Renal failure requiring hemo- or peritoneal dialysis
- •Child-Pugh C hepatic impairment
- •Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry
- •Known central nervous system tumors including metastatic brain disease
- •History of organ allograft
- •Substance abuse (current), psychological, or social conditions that may interfere with the patient's participation in the study or evaluation of the study results.
- •Known or suspected allergy to the investigational agents or any agent given in association with this trial.
- •Patients unable to swallow oral medications.
- •Pregnant or breast-feeding patients. Women of childbearing potential must have a negative pregnancy test performed within seven days prior to the start of the study drug. Both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial.
研究组 & 干预措施
1
Experimental
Songyou Granule
干预措施: Songyou (Drug)
2
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Time to tumor progression(TTP)
时间窗: Dec 2008 to Dec 2010
次要结局
- Overall survival (OS)(Dec 2008 to Dec 2010)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
3 期
The Clinical Trial of Chinese Herbal Medicine (SaiLuoTong) CapsuleVascular DementiaNCT03789760Shineway Pharmaceutical Co.,Ltd493
已完成
2 期
Lingzhi and Sen Miao San for the Treatment of Rheumatoid ArthritisRheumatoid ArthritisNCT00432484Chinese University of Hong Kong70
Unknown
2 期
The Clinical Trial of Chinese Herbal Medicine SaiLuoTong CapsuleVascular DementiaNCT01978730Shineway Pharmaceutical Co.,Ltd372
已完成
1 期
Prevention of Oral Malodor With an Oral Sticker Containing Herbal FormulaHalitosisOral MalodorBad BreathNCT00250289Hadassah Medical Organization15
已完成
不适用
A 3 month clinical trial of herbal medicine combination intended for topical application in patients with leg symptoms complaints due to chronic venous insufficiency: a double-blind randomized controlled trialChronic venous insufficiencyCirculatory SystemVenous insufficiency (chronic) (peripheral)ISRCTN54360155ational Research University Project, Office of the Higher Education Commission (WCU-58-034-AS)42