hepatocellular carcinoma
Conditions
Interventions
Group 1:PD-1 inhibitor combined with TACE
Sponsors
Hepatobiliary Surgery Department,Shanghai Public Health Clinical Center
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Aged 18-75 years; 2.CNCL(2019) stage I-IIIa,HCC is diagnosed by pathologist after hepatectomy; 3.High HCC recurrence-risk(at least 1 item met): a.Single tumor >= 5cm; b.More than one tumor; c.Gd-EOB-DTPA enhanced MRI and ihtra-operation prove tumor could be R0 resected or combinded with ablation; d.PVTT type I-II; MVI2(MVI1 with a.) is proved by pathologist; e.AFP>=400ng/ml. 4.Gd-EOB-DTPA enhanced MRI, DSA, chest CT do not find intra-/extra-liver tumor is found 4+/-1 weeks after operation.
Exclusion criteria
Exclusion criteria: 1.Not R0 resection or intra-/extra-liver tumor is found 4+/-1 weeks after operation; 2.PVTT type III-IV; 3.Over screening schedule date; 4.Ever used PD-1/PD-L1 inhibitor or other anti-tumor medicine 4 weeks before or after operation; 5.Child-Pugh score >= 8 or with ascites, Cr > UN,eGFR < 90, WBC <= 3.0 x 10^9/L,PLT<= 60x10^9/L, abnormal thyroid function, ECOG score 2-4, blood CD4+ count < 200; 6.Combind with immuno-disease, sentive to PD-1 inhibitor,mild/severe pheumonia, myocarditis,heart funtion equal or more than grade 2,pregnancy,active viral hepatitis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recurrence free survival time and recurrence free survival rate within 2 years after operation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival time and 1 -, 3 -, 5-year survival rate;Safety Evaluating; | — |
Countries
China
Contacts
Public ContactHuang Yangqing
Hepatobiliary Surgery Department, Shanghai Public Health Clinical Center
Outcome results
None listed