Hepatocellular
Conditions
Interventions
Control group:Surgery followed by adjuvant sintilimab 200mg Q3W for up to one year.
Trial group:Sintilimab 200mg Q3W for 2 cycles + stereotactic radiotherapy 8Gy*3 fractions on D1, D3, D5, followed by adjuvant sintilimab 200mg Q3W for up to one year postoperatively.
Sponsors
Shandong First Medical University and Shandong Academy of Medical Sciences (Shandong Cancer Hospital &Institute)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Sign a written informed consent form prior to any study-related procedures; 2. Male or female subjects aged >=18 years and 3 months; 12. At least one measurable lesion according to RECIST 1.1 or mRECIST criteria; 13. Adequate organ and bone marrow function, as follows: (1) Hematology: Absolute neutrophil count (ANC) >=1.5×10^9/L; platelet count (PLT) >=75×10^9/L; hemoglobin (HGB) >=9.0 g/dL; (2) Liver function: Total bilirubin (TBIL) =28 g/L; (3) Renal function: Serum creatinine (Cr) =50 mL/min (Cockcroft-Gault formula); urinalysis shows urine protein =2+, a 24-hour urine collection must be performed with 24-hour urinary protein quantification =12 weeks.
Exclusion criteria
Exclusion criteria: 1. History of any other malignancy confirmed by histology/cytology other than HCC; 2. History of hepatic encephalopathy or liver transplantation; 3. Presence of any extrahepatic metastatic lesion; 4. Prior receipt of any systemic anti-tumor therapy for HCC, including antibody treatments targeting PD-1, PD-L1, or CTLA-4; 5. Active or chronic hepatitis B or C infection: HBV DNA >2000 IU/ml or 10^4 copies/ml; HCV RNA >10^3 copies/ml; HBsAg and anti-HCV antibody both positive; 6. Received radiotherapy within 3 weeks prior to first dose; 7. HIV-infected individuals (HIV 1/2 antibody positive) or known syphilis infection; 8. Active or poorly controlled severe infection; 9. History of active autoimmune disease requiring systemic treatment within 2 years prior to first dose; 10. Known history of primary immunodeficiency. Patients with only positive autoantibodies must be evaluated by the investigator to confirm presence of autoimmune disease; 11. Use of immunosuppressive agents within 4 weeks prior to first dose, excluding intranasal, inhaled, or other local corticosteroids or physiologic-dose systemic corticosteroids (i.e., =10 mg/day prednisone or equivalent); temporary use of corticosteroids to manage dyspnea due to asthma or COPD is permitted; 12. Received or planned to receive live attenuated vaccines within 4 weeks prior to first dose or during the study; 13. Received locoregional therapy for hepatocellular carcinoma within 4 weeks prior to first dose; 14. Diagnosis of another malignancy within 5 years prior to first dose, excluding adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, and/or completely resected in situ carcinomas. If another malignancy or HCC was diagnosed more than 5 years prior to dosing, pathological or cytological confirmation of recurrent/metastatic lesions is required; 15. Known hypersensitivity to any component of sintilimab formulation; or prior severe allergic reaction to other monoclonal antibodies or tyrosine kinase inhibitors; 16. Received treatment in another clinical trial within 4 weeks prior to first dose; 17. Pregnant or lactating females; 18. Other acute or chronic diseases, psychiatric disorders, or abnormal laboratory values that may increase the risk of study participation or study drug administration, or interfere with interpretation of study results, and which, in the investigator’s judgment, render the patient ineligible for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3-year recurrence rate;Disease Control Rate;Pathologic Complete Response;Major Pathological Response; | — |
Secondary
| Measure | Time frame |
|---|---|
| 5-year recurrence rate;Recurrence-free survival;Overall Survival;Objective Response Rate; | — |
Countries
China
Contacts
Public ContactZhao Lei
Shandong First Medical University and Shandong Academy of Medical Sciences (Shandong Cancer Hospital &Institute)
Outcome results
None listed