Phase II Study of S-1 Combined With Calcium Folinate to Treat Advanced Hepatocellular Carcinoma
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- DCR
研究概览
简要总结
S-1 is a new chemotherapy drug. Some phase II trials showed S-1 is effective in Hepatocellular Carcinoma (HCC). S-1 combined with calcium folinate (SL) showed very good efficiency and safety in colorectal cancer (CRC). The short duration (two weekly regimen) is better than common course 4 week regimen in tolerance. So the investigators want to examine the efficiency and safety of SL one week on and one week off regimen in HCC.
详细描述
S-1 is a new chemotherapy drug. Some phase II trials showed S-1 is effective in HCC. S-1 combined with calcium folinate (SL) showed very good efficiency and safety in CRC. The short duration (two weekly regimen) is better than common course 4 week regimen in tolerance. So the investigators want to examine the efficiency and safety of SL one week on and one week off regimen in HCC.
SL one week on and one week off regimen will be give to advanced HCC patients. The primary endpoint is durable complete response (DCR).
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, 70 years > Age > 18 years
- •Patient with unresectable primary hepatocellular carcinoma
- •Child-Pugh Class A or B, without ascites
- •ECOG score 0
- •At least one tumor nodule can be evaluated by CT or MRI
- •Can take medicine orally
- •Expected survival time not less than 12 weeks
- •Women of childbearing potential must have a negative pregnancy test performed within 7 days prior to enrolling in this portion of the study During the trial and 4 week after the trial, must take contraception
- •Patients must be:
- •Hemoglobin > 9.0g/dl
- •ANC > 1.5×109/L
- •Platelet ≥ 60×109/L
- •Total bilirubin < 3mg/dl
- •ALT or AST < 5 X ULN
- •ALP < 4 X ULN
- •PT-INR < 2.3
- •Patients who is taking Warfarin , should be tested every week till getting stable INR
- •Serum creatinine < 1.5 X ULN
- •Serum amylase and lipase < 2 X ULN
排除标准
- •Known or suspected allergy to any agent given in association with this trial
- •Local treatment within 4 weeks prior to start of study drug
- •History of any heart disease
- •History of HIV infection except for HBV and HCV
- •Active clinically serious infections (> 2 NCI-CTC Version 3.0)
- •Clinically significant gastrointestinal bleeding within 4 weeks prior to study entry.
- •Embolization or infarction such as transient ischemic disease, deep vein thrombosis, pulmonary embolization within 6 months prior to study entry
- •Previous malignancy (except for cervical carcinoma in situ, adequate treated basal cell carcinoma, or superficial bladder tumors [Ta, Tis and T1], early gastric cancer, or other malignancies curatively treated > 3 years prior to entry
- •Extrahepatic tumor spread which affects patient's prognosis, such as bony metastasis or brain metastasis
- •Hydrothorax， ascites and hydropericardium need to drain
- •Serious diarrhea
- •Combined with serious pulmonary diseases, such as interstitial pneumonia, pulmonary fibrosis and serious pulmonary emphysema
- •Serious complication,such as intestinal obstruction,renal insufficiency, hepatic insufficiency and cerebrovascular disorders
- •Pregnant or breast-feeding
- •Any condition that is unstable or could jeopardize the safety of the patient and its compliance in the study, in the investigator's judgment.
- •Gastrointestinal disease that may affect to the absorption of drug or pharmacokinetics.
- •Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in this study
- •Patients unable to swallow oral medications.
研究组 & 干预措施
S-1 combined with LV
S-1 combined with LV
干预措施: S-1 combined with Leucovorin (Drug)
结局指标
主要结局
DCR
时间窗: in two years
DCR means patient got the best reaction and last for more than 4 weeks DCR=（CR）+ （PR）+ （SD） by RESIST 1.1
次要结局
- TTP ( time to progression)(in 2 years)
- OS ( overall survival)(in two years)
- safety(in two years)
研究者
Xie feng
attending physician
Second Military Medical University