HCC combined with microvascular tumor thrombus
Conditions
Interventions
Treatment group:anti-PD-1 200mg Q3W, 6mongths
observation group:observe
Sponsors
The Third Affiliated Hospital of the Second Military Medical University (Eastern Hepatobiliary Surgery Hospital)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 20 to 70 years; Pathologically diagnosis:liver cancer combined with MiVi(Stage I), which is deemed resectable and resected by two senior professional liver surgeons; 2. No other metastasis; 3. EHBH-MVI >4; 4. ECOG 0-1; Child A or B 7; 5. Pathologically diagnosis HCC with mvi; 6. heart, lung and kidney functional, no HCV, HIV or syphilis infection; 7. TACE confirmed no recurrence 1 month after surgery; 8. All patients should sign ICF.
Exclusion criteria
Exclusion criteria: 1. Child C before surgery, estimated to be intolerant to surgery, extrahepatic metastasis 2. intrahepatic recurrence or extrahepatic recurrence within 1 month post surgery; Child B grade 8-9, Child C, intolerance with Sintilimab treatment; 3. intolerable side effect or clinical accident when receiving Sintilimab treatment for the first time; 4. Unstable angina, symptomatic congestive heart failure, severe arrhythmia, myocardial infarction in the past 6 months, prolonged QT interval (>450ms); 5. Malignant tumors in other areas appeared in last 5 years; 6. The patient cannot be followed up or is participating in other clinical trials.For women of gestational age, no pregnancy plan and continued full contraception. 7. Pregnant women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| RFS;OS; | — |
Secondary
| Measure | Time frame |
|---|---|
| tumor marker;side reaction; | — |
Countries
China
Contacts
Public ContactWangKang ChengShunqun
The Third Affiliated Hospital of the Second Military Medical University(Eastern Hepatobiliary Surgery Hospital )
Outcome results
None listed