Effect of Biejia-Ruangan Compound on Survival Rate and Recurrence Rate of Hepatocellular Carcinoma After Radical Treatment
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 704
- 主要终点
- Recurrence-free survival
研究概览
简要总结
This study plans to enroll 704 patients with a history of chronic hepatitis B who have undergone radical treatment for hepatocellular carcinoma. The subjects were divided into a control group (conventional treatment group) and a combination therapy group (conventional treatment plus Biejia-Ruangan compound) according to the doctor's clinical diagnosis and treatment and the subjects' wishes in a ratio of 1:2. The subjects in the combination therapy group were treated with Biejia-Ruangan compound for 72 weeks, followed by 168 weeks of follow-up, for a total study period of 240 weeks.
By analyzing the 1-, 2-, 3-, and 5-year recurrence-free, overall survival rate/survival time, adverse reactions, etc., the clinical effect of Biejia-Ruangan compound in reducing the risk of recurrence in patients with hepatocellular carcinoma after receiving radical treatment was comprehensively evaluated, and its scientific value and practical application prospects as a potential treatment method were explored.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age range: 18-75 years old (including 18 and 75 years old), regardless of gender.
- •Individuals with chronic hepatitis B liver fibrosis or cirrhosis.
- •According to the "Diagnosis and Treatment Guidelines for Primary Liver Cancer" (2024 edition) liver cancer diagnosis roadmap, the first clinical diagnosis is Hepatocellular carcinoma(HCC).
- •The staging of liver cancer is CNLC stage Ia - IIa.
- •Radical treatment has been completed, with surgical resection or local ablation.
- •8-12 weeks after radical surgery, imaging and serological evaluations showed no residual cancerous lesions and no new cancerous lesions were found.
- •Child Pugh score A/B.
- •Voluntarily joining the group, able to understand and sign an informed consent form.
排除标准
- •Pregnant and lactating women;
- •Prior to radical liver cancer surgery, the patient had received radiation, chemotherapy, molecular targeting, immunotherapy, and other anti-tumor treatments;
- •Receive other anti-tumor Chinese medicine (including traditional Chinese patent medicines and simple preparations or Chinese herbal medicine);
- •Individuals with mental illnesses, especially those with a history of depression, anxiety, mania, schizophrenia, or a family history of mental illness (especially those with a history of depression or tendencies towards depression);
- •Combination of hepatitis A, C, D, E, and/or current HIV infections;
- •Kidney diseases: acute and chronic nephritis, renal insufficiency, nephrotic syndrome, etc., or screening with blood creatinine>2.0 × ULN;
- •Autoimmune diseases, including psoriasis, systemic lupus erythematosus, autoimmune liver disease, etc;
- •Patients who experience upper gastrointestinal bleeding within the first 3 months (including the screening period) prior to screening;
- •Individuals with a serious history of heart disease, especially those with unstable or poorly controlled heart disease within the past 6 months;
- •Individuals who plan to receive organ transplantation or have already undergone organ transplantation;
- •Those who are allergic to Compound Biejia Ruangan Tablets, nucleoside (acid) analogues, or drug excipients, or who meet any contraindications in the experimental drug instructions;
- •Have used other anti fibrotic drugs within the first 6 months of enrollment, such as Fuzheng Huayu, Anluo Huaxian, and Ganshuang Granules.
- •Other situations where the participant has participated in other intervention trials within the previous month or where the researcher deems it unsuitable for inclusion.
研究组 & 干预措施
Control group
Conventional treatment
干预措施: Routine medical care (Other)
Treatment group
Conventional treatment plus Biejia-Ruangan compound
干预措施: Routine medical care (Other)
Treatment group
Conventional treatment plus Biejia-Ruangan compound
干预措施: Biejia-Ruangan compound (Drug)
结局指标
主要结局
Recurrence-free survival
时间窗: 96 weeks
次要结局
- Overall survival rate(96 weeks)
- quality of life (QOL) questionnaire(96 weeks)
研究者
Zhiyun Yang
Vice President of Beijing Ditan Hospital Affiliated to Capital Medical University
Beijing Ditan Hospital