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:
2025-12-24 @ 9:18 PM
Ignite Modification Date:
2025-12-24 @ 9:18 PM
NCT ID:
NCT02748304
Eligibility Criteria:
Inclusion Criteria:
* The characteristics of the treatment history:
1. No sorafenib treatment history, no sorafenib allergies.
2. No chemotherapy, radiotherapy and transcatheter arterial chemoembolization(TACE) treatment history before surgery.
* The characteristics of the tumor:
1. The pathological results is hepatocellular carcinoma.
2. Meet any of the following articles:
* Pathological prompt microvascular invasion(MVI) class II, and incorporate any of the following:Tumor number\>3,Tumor size\>8cm,Tumor margin is not clear and no complete capsule.
* With the embolus in Portal vein, hepatic vein or bile duct.
* Preoperative rupture or invasion the adjacent organs.
* The positive cut edge.
* Residual lesions showed by Postoperative digital subtraction angiography(DSA).
* Alpha fetoprotein(AFP) did not drop to normal range two months after surgery.
* The characteristics of the patients:
1. The patient age was between 18-75.
2. The American Society of Anesthesiologists(ASA）score was I-III.
3. No history of esophageal varices and gastrointestinal bleeding.
4. The Child-pugh score was A.
5. Routine blood test: the leukocyte\>2.5\*10\^9, platelet\> 60\*10\^9.
6. The Prothrombin time was prolonged less than 2 second.
7. The Eastern Cooperative Oncology Group(ECOG) score was less than 2 points
Exclusion Criteria:
* Sorafenib treatment before surgery.
* Pregnant or lactating women.
* The Child-pugh score was B-C.
* Patients with other malignant tumor.
* Patients with mental illness.
* Patients participated in other clinical trials in last three months.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02748304
Study Brief:
Protocol Section:
NCT02748304