ITMCTR2200006056尚未招募未知
Huqizhengxiao decoction combined with targeted drugs in the treatment of stage III HBV-related hepatic carcinoma:a pragmatic randomized controlled clinical study
Beijing Youan Hospital, Capital Medical University, Beijing, China.0 个研究点开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional study
入排标准
- 年龄范围
- 18 至 75（—）
- 性别
- All
入选标准
- •1) 18-75 years old, male or female;
- •2) Life expectancy greater than 3 months;
- •3) Met the criteria to be diagnosed with chronic hepatitis B prevention guide (2015 edition) of chronic hepatitis b diagnosis standards;
- •4) Met the criteria to be diagnosed with primary liver cancer diagnosis and treatment standards (2017 edition) standard and clinical staging, diagnosis of primary liver cancer and accord with the phase III (stage IIIa, IIIb) in the diagnosis of conditions, liver function grade Child - PughA or class B, ECOG score 0 ~ 2; With vascular invasion and/or extrahepatic metastasis;
- •5) The enhanced imaging examination for at least one measurable lesions objective tumor response evaluation;
- •6) For the treatment of hepatitis b, has been used at least before in 1 ~ 2 kinds of antiviral drugs (according to the standard treatment for prevention and treatment, and agreed to continue their antiviral treatment during the study;
- •7) TCM syndrome type belong to the liver and spleen kidney deficiency, have phlegmy wet (and) or stasis poison implication;
- •8) In the early stage did not receive targeted therapy;
- •9) Signed informed consent.
排除标准
- •1) Pregnant or lactating women;
- •2) The combination of human immunodeficiency virus (HIV) infection or other severe infectious diseases;
- •3) Complicated with severe lung disease, primary renal disease and other serious systemic diseases and mental illness; On admission, fatal complications occurred, such as stage III or higher hepatic encephalopathy, cerebral edema, serious infection in other sites (including deep fungal infection, infection in more than two sites, double infection, etc.), hepatorenal syndrome, massive gastrointestinal bleeding, etc;
- •4) Despite the Child - Pugh, A - B, but A single serum total bilirubin > 51 umol/L(3ULN) and (or) amino transferase (AST and ALT) > 5 ULN, serum albumin < 28 g/L, or recurrent hepatic encephalopathy, infection, fever, ascites or hepatorenal syndrome; The coagulation function is severely reduced and cannot be corrected;
- •5) Tumor distant transfer extensively, estimated lifetime < 3 months;
- •6) Evil fluid to pledge or multiple organ failure;
- •7) With other malignant tumor;
- •8) Four weeks prior to the start of the study with other treatment liver cancer indications of the modern Chinese native medicine preparation (including but not limited to: Kanglaite injection/soft capsule, eddy injection, Kangai injection, Lanxiangxi injection, Huachansu capsule, Ganfule capsule, huai ear particles, etc.);
- •9) Four weeks prior to the start of the study had immune treatment;
- •10) Two weeks prior to the start of the study had major surgery, or surgery patients haven't recovered;
- •11) Accepted the other 4 weeks prior to the start of the study of research and development of new drugs or new therapy to treat patients;
- •12) Disagree to sign the informed consent;
- •13) Other conditions that the investigator considers inappropriate for participation in the study.
研究者
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