Liver Cancer
Conditions
Interventions
Fluorouracil implants +TACE:Fluorouracil implants
Sponsors
Shandong Cancer Hospital and Institute
Eligibility
Sex/Gender
All
Age
16 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1) HCC was diagnosed by histopathology / clinical diagnosis; 2) The evaluation of physical condition and liver function is suitable for surgical resection. 3) Aged 18-75 years; 4) ECoG score was 0-2; 5) The expected survival time was more than 3 months; 6) The function of the main organs is normal, that is to say, it meets the following standards: The blood routine examination standard should meet the following requirements: a. Hemoglobin >= 70g / L; b. WBC count >= 2.0 x 10^9 / L; c. The absolute neutrophil count was more than 0.5 x 10^9 / L; Biochemical examination should meet the following standards: a. Total bilirubin 60ml / min (Cockcroft Gault formula) 7) They were enrolled voluntarily, signed informed consent, and had good compliance and follow-up; 8) One of the following risk factors for poor prognosis was found MVI was the result of preoperative imaging evaluation or postoperative pathology; Tumor diameter > 5cm; The number is more than 2; Satellite foci were found around the tumor; The cutting edge was less than 1cm; There was no obvious pseudocapsule or invasion of liver capsule; AFP > 400 ng / ml. 9) Postoperative adjuvant TACE should be performed between 4 and 6 weeks after surgery.
Exclusion criteria
Exclusion criteria: 1) They were complicated with uncontrollable central nervous system metastasis, intracranial hypertension, severe chronic obstructive pulmonary disease and / or respiratory failure, severe intestinal adhesion, and so on; 2) They had bleeding tendency, especially had obvious gastrointestinal bleeding within 4 weeks, or were receiving thrombolytic or anticoagulant therapy; 3) Myocardial infarction occurred within 6 months, or unstable angina pectoris and cardiac insufficiency were present; 4) Participated in any drug clinical research within 6 months; 5) Patients with poor compliance, or suffering from mental illness, can not self-control; 6) Known to be allergic to the test drug and its excipients; 7) At present, there are serious uncontrolled infections; 8) Women in pregnancy or lactation, and patients of childbearing age (including men) who are unwilling to take contraceptive measures; 9) Patients with previous allergy to fluorouracil and its derivatives; 10) Other situations in which the researchers believe that patients should not participate in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease-free survival, DFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, OS; | — |
Countries
China
Contacts
Public ContactKai Cui
Shandong Cancer Hospital and Institute
Outcome results
None listed