Clinical trial NCT02399033: Xihuang Capsules Prevention of Recurrence in Patients With Hepatocellular Carcinoma After Hepatectomy
Official title: Xihuang Capsules Prevention of Recurrence in Patients With Hepatocellular Carcinoma After Hepatectomy: A Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hepatocellular Carcinoma
Keywords: Xihuang Capsules
hepatocellular carcinoma
Recurrence
hepatectomy
Lead sponsor: Eastern Hepatobiliary Surgery Hospital
Sponsor class: OTHER
First posted: 2015-03-26
Enrollment: 1000
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. Age: 20-70 years old;
2. Gender: male or female;
3. clinical or pathological diagnosis of hepatocellular carcinoma (HCC) in previously untreated patients;
4. The expected survival\> 3 months;
5. Child-Pugh grade in A-level;
6. KPS score with 50-100 points;
7. 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.
8. women in the reproductive period must be completely contraception in 28 days before treatment, during the treatment process and in 28 days after treatment;
9. Men must be completely contraception and prohibited donation and sperm donation during the treatment process and in 28 days after treatment;
10. All patients must be prohibited donation during the treatment process and in 28 days after treatment;
11. In addition to the subjects, prohibitting other people taking this product.
12. patients have a good understanding and could coordinate with investigators for the trial.
13. 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.

Exclusion Criteria:

1. Because of suffering from any serious illness,laboratory abnormalities or mental abnormalities,the patient is unable to sign an informed consent form;
2. patients with medical abnormalities may result in that the trial could not be evaluated or have security risks;
3. persons who are unable to take oral drugs.
4. coagulation dysfunction;
5. HIV, syphilis-infected persons;
6. persons who have a serious heart, liver and renal failure;
7. persons who are known to allergic to the drug or any component of the drug;
8. persons who are received experimental therapy in 28 days before the first treatment;
9. 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;
10. lactating or pregnant women;
11. patients in the reproductive period are unwilling or unable to contraception;
12. persons with poor medication compliance;
13. The researchers considered unsuitable selected patients.

Primary outcomes:
measure: Hepatocellular carcinoma recurrence rate in the three years after hepatectomy
timeFrame: in the three years after hepatectomy
Secondary outcomes:
measure: Hepatocellular carcinoma recurrence rate in a year after hepatectomy
timeFrame: in a year after hepatectomy
measure: Relapse free survival (RFS)
timeFrame: up to 5 years
measure: Hepatocellular carcinoma survival rate in a year or three years after hepatectomy
timeFrame: in a year or three years after hepatectomy
measure: Overall survival(OS)
timeFrame: up to 5 years
measure: Improvement in quality of life in a year or three years after hepatectomy
timeFrame: in a year or three years after hepatectomy
measure: number of participants with improvement of clinical symptoms, Such as flank pain, bloating, fatigue, anorexia and other syndromes of traditional Chinese Medicine.
timeFrame: participants will be followed for the duration of study, an expected average of 3 months.
measure: The incidence of adverse reaction.
timeFrame: up to 5 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Eastern Hepatobiliary Surgical Hospital
state: Shanghai
Study officials:
affiliation: Eastern Hepatobiliary Surgical Hospital
name: Shuqun Cheng, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: