Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:56 AM
Ignite Modification Date:
2025-12-25 @ 2:56 AM
NCT ID:
NCT02399033
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
70 Years
Study:
NCT02399033
Study Brief:
Protocol Section:
NCT02399033