An Open-label, Single-institution, Non-randomized, Single-arm, Pilot Study of Jiu-wei-zhen-xiao Granule for the Treatment in Patients With Advanced Hepatocellular Carcinoma
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Overall Survival
研究概览
简要总结
This is a piolt single-arm trial of Jiu-wei-zhen-xiao Granule, extracted from nine kinds of Chinese medicnie, for the treatment in patients with advanced, unresectable hepatocellular carcinoma(HCC). The primary objective is to assess its therapeutic efficacy in patients with unresectable HCC. The primary endpoint is overall survival (OS) after the use of 12-week drug. Secondary endpoints include progression-free survival (PFS) after the use of 12-week drug, the improvement of the score of the European Organization for Reasearch and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30), the changes of the liver function, coagulation function, the size of solid tumors,"Du-tan-yu-jie Zheng" in Chinese medicine, pain Visual Analogue Scale and toxicity profile of Jiu-wei-zhen-xiao Granule.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age:18~75 years;
- •Patients must have diagnosis of advanced hepatocellular cancer (HCC) by one of the following:
- •(1) Histopathology; (2) Elevated serum alpha-fetoprotein (AFP) >400 ng/ml and findings on magnetic resonance imaging (MRI) or computed tomography (CT) scans characteristic of HCC; (3) Findings on triple phase MRI or CT scans characteristic of HCC in patients with cirrhosis and tumors at least 1 cm or greater, without a curative treatment option (transplant, resection, or ablation).
- •3.The clinical staging of HCC is B or C or D staging as the Barceln Clinical Liver Cancer Classification(BCLC);
- •Patients with hepatitis B virus infection;
- •Patients with "Du-tan-yu-jie Zheng" in Chinese medicine;
- •Karnofsky score ≥60;
- •Ability to understand and willingness to sign a written informed consent document.
排除标准
- •Patients with unstable vital signs;
- •Any uncontrolled, severe, intercurrent illness including but not limited to ongoing or active infection, heart, brain, lung and other systemic diseases or other kinds of tumors;
- •Known history of allergy to the ingredients of this product;
- •Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial through 120 days after the last dose of trial treatment;
- •Receipt of any other investigational agents ≤ 1 month of the first dose of study treatment;
- •Patients who cannot take oral medication.
研究组 & 干预措施
Jiu-wei-zhen-xiao Granule
Patients will be treated for 12 weeks, with oral administration of 5g once of Jiu-wei-zhen-xiao Granule,three times a day, based on the conventional treatment for HCC, such as antiviral treatment, supportive treatment or symptomatic treatment.
干预措施: Jiu-wei-zhen-xiao Granule (Drug)
结局指标
主要结局
Overall Survival
时间窗: Up to 12 weeks
Overall Survival (OS) is defined as the percentage of people in a group who are alive after the 12-week use of drug.
次要结局
- Progression-Free Survival(Baseline, 4 weeks, 8 weeks, 12 weeks)
- European Organization for Reasearch and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) (Chinese version, Version 3.0)(Baseline, 4 weeks, 8 weeks, 12 weeks)
- The level of the liver function(Baseline, 4 weeks, 8 weeks, 12 weeks)
- The level of AFP(Baseline, 4 weeks, 8 weeks, 12 weeks)
- The level of coagulation function(Baseline, 12 weeks)
- The size of solid tumors(Baseline, 12 weeks)
- "Du-tan-yu-jie Zheng" symptoms score in Chinese medicine(Baseline, 4 weeks, 8 weeks, 12 weeks)
- 10cm-VAS of the pain(Baseline, 4 weeks, 8 weeks, 12 weeks)
研究者
Zhong Wang
Vice-director
China Academy of Chinese Medical Sciences