Xihuang Capsules Prevention of Recurrence in Patients With Hepatocellular Carcinoma After Hepatectomy

Shuqun Cheng

Status and phase: Unknown; Phase 4

Conditions: Hepatocellular Carcinoma

Treatments: Drug: Xihuang Capsules

Study type: Interventional

Funder types: Other

Identifiers

NCT02399033

SCheng

Details and patient eligibility

About

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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,000 participants in 2 patient groups

the control group

No Intervention group

Description:

Patients in Control group were not received Xihuang Capsules.

Xihuang Capsules group

Experimental group

Description:

Patients in Xihuang Capsules group were received Xihuang Capsules (2g, bid), Continuously taking to cancer recurrence or death.

Treatment:

Drug: Xihuang Capsules