Sorafenib Combined With Aspirin to Prevent the Recurrence in High-risk Patients With Hepatocellular Carcinoma

• Status: Terminated
• Trial end date: 2019-02-11
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to observe the effect of sorafenib combined with aspirin in preventing the recurrence in high-risk patients with hepatocellular carcinoma.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fudan University
• Treatments: Aspirin; Niacinamide; Sorafenib

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.