Xihuang Capsules Prevention of Recurrence in Patients With Hepatocellular Carcinoma After Hepatectomy: A Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Hepatocellular carcinoma recurrence rate in the three years after hepatectomy
研究概览
简要总结
Study Objective: To evaluate the efficacy and safety of Xihuang Capsules prevention of recurrence in patients with hepatocellular carcinoma after hepatectomy.
Study Design: The study was A Multicenter, Randomized, Controlled, Open-Label, Parallel-Group Clinical Trial. Patients will be randomly assigned to Xihuang Capsules group or the control group by the proportion of 2: 1.
The total sample size: 1000 cases. Study Process: The study is divided into three phases: the screening phase, treatment phase, follow-up phase.To complete screening in two weeks, patients who fit the criteria were randomly assigned to Xihuang Capsules group or the control group.In two weeks after hepatectomy, Xihuang Capsules group received Xihuang Capsules (2g,bid), Continuously taking to cancer recurrence or death.Control group was not received Xihuang Capsules. In the first month to three years after treatment, Conducting visits for once every three months,to evaluate the efficacy and safety with hepatocellular carcinoma recurrence rate in the three years after hepatectomy as the primary outcome. When entering the follow-up phase, Keeping in touch with patients withdrew from the study for a clinic or telephone follow-up every three months.
From signing informed consent till the end of the study, inspecting the adverse events and concomitant medications for all subjects in each visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 20-70 years old;
- •Gender: male or female;
- •clinical or pathological diagnosis of hepatocellular carcinoma (HCC) in previously untreated patients;
- •The expected survival> 3 months;
- •Child-Pugh grade in A-level;
- •KPS score with 50-100 points;
- •In two weeks after hepatectomy for R0 resection surgery. Preoperative must meet the following criteria:
- •BCLC stage of 0-B;
- •conform to the indications of hepatectomy;
- •Viable tumor resection confirmed by two highly qualified surgical doctors;
- •No other surgical contraindications.
- •women in the reproductive period must be completely contraception in 28 days before treatment, during the treatment process and in 28 days after treatment;
- •Men must be completely contraception and prohibited donation and sperm donation during the treatment process and in 28 days after treatment;
- •All patients must be prohibited donation during the treatment process and in 28 days after treatment;
- •In addition to the subjects, prohibitting other people taking this product.
- •patients have a good understanding and could coordinate with investigators for the trial.
- •Patients enrolled in the trial should sign an informed consent form, to indicate understanding the purpose and procedure of the trial, and patients volunteering to participate in the trial.
排除标准
- •Because of suffering from any serious illness,laboratory abnormalities or mental abnormalities,the patient is unable to sign an informed consent form;
- •patients with medical abnormalities may result in that the trial could not be evaluated or have security risks;
- •persons who are unable to take oral drugs.
- •coagulation dysfunction;
- •HIV, syphilis-infected persons;
- •persons who have a serious heart, liver and renal failure;
- •persons who are known to allergic to the drug or any component of the drug;
- •persons who are received experimental therapy in 28 days before the first treatment;
- •persons who are received radiotherapy or other surgery(including of the other local surgery for cancer treatment,eg. TACE) in addition to hepatectomy in 14 days before the first treatment;
- •lactating or pregnant women;
- •patients in the reproductive period are unwilling or unable to contraception;
- •persons with poor medication compliance;
- •The researchers considered unsuitable selected patients.
研究组 & 干预措施
Xihuang Capsules group
Patients in Xihuang Capsules group were received Xihuang Capsules (2g, bid), Continuously taking to cancer recurrence or death.
干预措施: Xihuang Capsules (Drug)
结局指标
主要结局
Hepatocellular carcinoma recurrence rate in the three years after hepatectomy
时间窗: in the three years after hepatectomy
Diagnostic criteria for hepatocellular carcinoma recurrence: refer to Chinese Anti-Cancer Association Professional Committee of hepatocellular carcinoma developed diagnostic criteria for primary hepatocellular carcinoma belong to Guangzhou standard in 2001. Once new or suspected place nature lesions within liver were found by B-ultrasonography examination,we should do CT, MRI or PET-CT review, in order to confirm the diagnosis. If imaging is positive, diagnosing hepatocellular carcinoma(dominant) recurrence after treatment; if imaging is negative, but AFP values\> 400μg/L or ongoing elevated AFP values, diagnosing hepatocellular carcinoma occult recurrence after treatment.
次要结局
- Overall survival(OS)(up to 5 years)
- Improvement in quality of life in a year or three years after hepatectomy(in a year or three years after hepatectomy)
- Hepatocellular carcinoma survival rate in a year or three years after hepatectomy(in a year or three years after hepatectomy)
- Relapse free survival (RFS)(up to 5 years)
- The incidence of adverse reaction.(up to 5 years)
- Hepatocellular carcinoma recurrence rate in a year after hepatectomy(in a year after hepatectomy)
- number of participants with improvement of clinical symptoms, Such as flank pain, bloating, fatigue, anorexia and other syndromes of traditional Chinese Medicine.(participants will be followed for the duration of study, an expected average of 3 months.)
研究者
Shuqun Cheng
Xihuang Capsules prevention of recurrence in patients with hepatocellular carcinoma after hepatectomy: A multicenter randomized controlled trial.
Eastern Hepatobiliary Surgery Hospital