HCC
Conditions
Interventions
Postoperation(adjuvant):donafenib (100mg Bid,oral)combined with tislelizumab(200mg,Q3W,intravenous infusion)for six months
observation group:Preoperation(neoadjuvant):donafenib (100mg Bid,oral),tislelizumab(200mg,Q3W,intravenous infusion)for 2 cycles
Surgery
Sponsors
Third Affiliated Hospital of Naval Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.The patient volunteered to participate in the study and signed an informed consent form; 2.=18 years of ageMale or female; 3.Proven hepatocellular carcinoma according patological examination or AASLD diagnostic criteria; 4.Subjects are diagnosed with resectable BCLC A/B HCC cancer; 5.Subjects haven't received any systemic treatment(except for antiviral therapy) or local therapy for HCC before admission,at least one measurable lesion that met the definition of mRECIST standard; 6.Beyond Milan criteria: a)Single tumor diameter>5cm b)2-3 tumors with the largest tumor diameter>3cm c)multiple lesions>3 7.Child-Pugh 5~7; 8.ECOG PS=1; 9.Life expectancy = 3 months; 10.Hemoglobin=90 g/L;absolute neutrophil count=1.5×10^9/L;Platelet=75×10^9/L; 11.Albumin=28 g/L;total bilirubin=1.5 times upper limit of normal values (ULN);liver transaminases (ALT and AST) =5 times ULN;serum creatinine=1.5 times ULN or creatinine clearance =60 mL/min (calculated by Cockcroft-Gault formula); 12.International normalised ratios or prothrombin time=1.5×ULN;activated partial thromboplastin time=1.5×ULN; 13.Normal thyroid function.
Exclusion criteria
Exclusion criteria: 1.Known hepatocholangiocarcinoma, sarcomatoid HCC, mixed cell carcinoma and lamellar cell carcinoma; other active malignant tumor except HCC within 5 years or simultaneously; 2.Recurrent HCC; 3.Known history of other malignancy; 4.A history of immunodeficiency, including HIV-positive or other acquired, congenital immunodeficiency disease; 5.The patient has any active autoimmune disease or a history of autoimmune disease expected relapse; 6.Factors to evidently affect drug absorption; 7.Patients who underwent surgical treatment within 4 weeks prior to the start of study treatment; 8.Be ready for or previously received organ or allogenic bone marrow transplantation; 9.Be allergic to related drugs such as donafenib and PD1 antibody ; 10.Thrombosis or thromboembolic event within 6 months prior to the start of study treatment; 11.History of gastrointestinal hemorrhage within 4 weeks prior to the start of study treatment or clear tendency of gastrointestinal hemorrhage; 12.Received other systemic anti-tumor treatments; 13.History of active bleeding or coagulation dysfunction that are considered to have high risk of bleeding,receiving thrombolysis, anticoagulation or antiplatelet therapy; 14.With uncontrollable hepatic encephalopathy, hepatorenal syndrome, ascites, pleural effusion or pericardial effusion ; 15.Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of this protocol; 16.Known human immunodeficiency virus (HIV) infection; 17.Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation and in the judgment of the investigator would make the patient inappropriate for entry into this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recurrence free survival rates of 12 months;Recurrence free survival(RFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR;Major pathologic response;Pathological complete response; | — |
Countries
China
Contacts
Public ContactCheng Shuqun
Third Affiliated Hospital of Naval Medical University
Outcome results
None listed