Hepatocellular Carcinoma
Conditions
Interventions
Treatment Group:Sindilizumab (200mg, iv, Q3W) combined with Donafenib 100mg, po, bid
Sponsors
Nanjing Drum Tower Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Join the group voluntarily and sign a written informed consent; 2) Age 18-75 years old (including 75 years old), male and female; 3) Stage CNLCIa-IIIb patients underwent radical resection of liver cancer 4 to 8 weeks before enrollment; 4) Pathological diagnosis of hepatocellular carcinoma, with any of the following conditions: a) tumor rupture; b) microvascular or macrovascular invasion; c) Poor tumor differentiation (Edmondson III to IV grade); d) Tumor diameter > 5cm; e) Multiple tumors (=3); f) lymph node metastasis; g) Narrow incisal margin ( 3 months; 9) HBV DNA < 104 copies /ml (2000IU/ml), if HBV DNA=104 copies /ml, antiviral therapy should be given first, and the study should be conducted until HBV DNA drops below 104 copies /ml, and antiviral drugs and liver function and hepatitis B viral load should be monitored. 10) Female patients who are fertile (meaning those who have not undergone menopause or have not undergone surgical sterilization) must have a negative serum pregnancy test result within 7 days prior to the administration of the study drug; 11) Fertile female or male patients must use reliable contraception during the study drug use and within 60 days after the last drug use; 12) Major organ function is normal, that is, meet the following criteria: Routine blood tests (no transfusions, no G-CSF use within 14 days prior to screening) : a) Hemoglobin =90 g/L; b) Absolute neutrophil count (ANC) =1.5×109/L; c) Platelet count =75×109/L; Blood biochemical tests (no albumin used in 14 days prior to screening) : d) Albumin =28 g/L; e) Total bilirubin =1.5× upper limit of normal (ULN); f) Aspartate aminotransferase (AST), alanine aminotransferase (ALT) =3×ULN; g) Creatinine =1.5×ULN; Coagulation function: h) International Standardized ratio (INR) or prothrombin time (PT) =1.5×ULN; i) Activated partial thromboplastin time (APTT) =1.5×ULN.
Exclusion criteria
Exclusion criteria: 1) Pathological diagnosis of hepatocellular carcinoma and intrahepatic cholangiocarcinoma (HCC-ICC) mixed type; 2) Positive incisal margin or tumor rupture; 3) Reoperation for recurrent liver cancer; 4) other malignancies within 5 years, unless the patient has received potentially curable treatment and there is no evidence of the presence of the disease within 5 years, but this time requirement (i.e., 5 years) does not apply to patients with cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma, superficial bladder carcinoma, cervical carcinoma in situ or other carcinoma in situ who have undergone successful resection; 5) Have been or are currently suffering from congenital or acquired immunodeficiency diseases; 6) Active or previously documented autoimmune or inflammatory diseases (including but not limited to:Autoimmune hepatitis, interstitial pneumonia, inflammatory bowel disease, systemic lupus erythematosus, vasculitis, uveitis, pituitaritis, hyperthyroidism or hypothyroidism, asthma requiring bronchodilator treatment, etc.), asthma with vitiligo or complete remission in childhood, adults without any intervention can be included; 7) Have a history of serious mental illness; 8) Have a disease that affects the absorption, distribution, metabolism, or clearance of the investigational drug (such as severe vomiting, chronic diarrhea, intestinal obstruction, malabsorption, etc.); Prior or combined medication/treatment: 9) had major surgery (as defined by the investigator) within the first 4 weeks of enrollment, or expected to require major surgery during the study treatment; 10) Have previously received allogeneic stem cells or parenchymal organ transplantation; 11) Received targeted drug therapy such as sorafenib, Renvastinib, regorafenib or immunomodulators such as anti-PD-1, anti-PD-L1, anti-CTLA-4 before surgery; 12) Patients who have received other systemic anti-tumor therapy before surgery, including Chinese medicines with anti-tumor indications, less than 2 weeks or 5 drug half-lives (whichever is longer) from the completion of treatment to the start of this study, or whose adverse events caused by preoperative treatment have not recovered to =CTCAE Grade 1; 13) Received other postoperative adjuvant therapy (except antiviral therapy); 14) Had used systemic immunosuppressive drugs within 2 weeks prior to enrollment, or expected to require systemic immunosuppressive drugs during the study period, except in the following cases: d) intranasal, inhaled, topical or local injections of corticosteroids (e.g. intra-articular injections); e) systemic corticosteroids with a dose not exceeding 10 mg/ day of prednisone or other equivalent effects; f) prophylactic use of corticosteroids for hypersensitivity; 15) Concurrent use of drugs that may prolong QTc and/or induce tip torsion ventricular Tdp or drugs that affect drug metabolism; Security: 16) Patients with a known or suspected history of allergy to Donafinil or similar drugs, or a history of hypersensitivity to chimeric or humanized antibodies or fusion proteins, or allergy to excipients of investigational drugs; 17) The presence of uncontrollable hepatic encephalopathy, hepatorenal syndrome, ascites, pleural effusion or pericardial effusion; 18) Have active bleeding or abnormal coagulation function, have bleeding tendency or are receiving thrombolytic, anticoagulant or antiplatelet therapy; 19) Have a history of gastrointestinal bleeding in the past 4 weeks or have a clear te
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of recurrence-free patients at 1 year; | — |
Secondary
| Measure | Time frame |
|---|---|
| Recurrence Free Survival, RFS;Overall Survival, OS;Time To Recurrence, TTR;Diachronic change of ECOG PS score;Diachronic change of quality of life score based on FACT-Hep scale;Diachronic variation of AFP;Safety evaluation index;Adverse events and serious adverse events analysis; | — |
Countries
China
Contacts
Public ContactXinhua Zhu
Department of Hepatobiliary Surgery, the Afliated Drum Tower Hospital of Nanjing University Medical School
Outcome results
None listed