Hepatocellular carcinoma
Conditions
Interventions
Test group:Donafenib and Sindillizumab combined with TACE
Sponsors
The Affiliated Hospital of Jining Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1) Join the group voluntarily and sign a written informed consent; 2) Age 18 ~ 80 years old (including 80 years old), male and female; 3) Patients with hepatocellular carcinoma clinically diagnosed or histologically/cytologically confirmed according to the Guidelines for Diagnosis and Treatment of Primary Liver Cancer (2022 Edition); 4) The subject is not suitable for or refuses radical treatment through hepatectomy or ablation; 5) Have not received systemic antitumor therapy. Patients who received adjuvant chemotherapy after local treatment, took >12 months to complete chemotherapy, and had disease progression or metastasis were also enrolled. 6) The subjects had received no more than 2 TACE treatments in the past and the efficacy was evaluated as CR, and the tumor recurrence occurred more than 6 months after the end of TACE treatment; 7) Patients who had previously undergone hepatectomy should have R0 resection, and tumor recurrence should be more than 24 months after surgery; 8) Have at least one evaluable lesion (RECIST 1.1 criteria); 9) Expected survival time =3 months; 10) The physical status (PS) score of the Eastern Cancer Collaboration Group (ECOG) was 0-1; 11)Child-Pugh score =7 points; 12) Major organ function is normal, that is, meet the following criteria: routine blood test: hemoglobin =90 g/L, neutrophil =1.5×10^9/L, platelet count =75×10^9/L Biochemical examination: Albumin =28 g/L, total bilirubin =3× upper limit of normal (ULN), aspartate aminotransferase (AST), alanine aminotransferase (ALT) =5×ULN, alkaline phosphatase (ALP) =5×ULN, creatinine =1.5×ULN International Standardized ratio (INR) or prothrombin time (PT) =1.5×ULN, activated partial thromboplastin time (APTT) =1.5×ULN; 13) If HBsAg (+) and/or anti-HCV (+), antiviral therapy should be standard based on HBV DNA or HCV RNA test results; 14) Women of reproductive age should have a negative serum or urine pregnancy test within 14 days prior to inclusion in the study, must be non-lactating women, and patients should consent to the use of contraceptives during medication and for 60 days after the end of medication; 15) The subjects had good compliance and cooperated with follow-up.
Exclusion criteria
Exclusion criteria: 1) fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma and other components previously confirmed by histology/cytology; 2) a history of malignancy other than hepatocellular carcinoma, unless the following criteria are met: a) The patient has received potentially curable therapy and there is no evidence of the disease within 5 years; b) skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder carcinoma, cervical carcinoma in situ and other carcinoma in situ after successful resection; 3) Diffuse neoplasms; 4) Extrahepatic metastasis or cancer thrombus invading the main portal vein, or involving the superior mesenteric vein and inferior vena cava cancer thrombus; 5) History of hepatic encephalopathy and hepatorenal syndrome; 6) Have been or are currently suffering from congenital or acquired immunodeficiency diseases; 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.); 9) Have previously received allogeneic stem cells or parenchymal organ transplants; 10) Received local treatment for liver cancer within the previous 4 weeks; 11) Previously received targeted therapy against VEGF and/or VEGFR, RAF, MEK and other signaling pathways such as sorafenib, Renvastinib, regorafenib, or immunomodulators such as anti-PD-1, anti-PD-L1, anti-CTLA-4; 12) Patients who have previously received other systemic anti-tumor therapy, including Chinese medicines with anti-tumor indications, less than 2 weeks after the completion of treatment to this study, or the adverse events caused by previous treatment have not recovered to =CTCAE grade 1; The toxic effects of previous anticancer treatments did not include alopecia and oxaliplatin induced grade 1/2 neurotoxicity; 13) Concurrent use of drugs that may prolong QTc and/or induce tip torsion ventricular Tdp or drugs that affect drug metabolism; 14) 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; 15) Have active bleeding or abnormal coagulation function, have bleeding tendency or are receiving thrombolytic, anticoagulant or antiplatelet therapy; 16) Thrombosis or thromboembolic events, such as stroke and/or transient ischemic attack, deep vein thrombosis, pulmonary embolism, etc., have occurred within the past 6 months; 17) Bleeding from esophageal or fundus varices caused by portal hypertension within 6 months, or any life-threatening bleeding event within 3 months; 18) Clinically significant cardiovascular disease, including but not limited to acute myocardial infarction, severe/unstable angina pectoris, or coronary artery bypass grafting within the previous 6 months, congestive heart failure (NYHA rating >2), poorly controlled arrhythmias that require pacemaker treatment, Hypertension not controlled by medication (systolic blood pressure =140 mmHg and/or diastolic blood pressure =90 mmHg); 19) Other significant clinical and laboratory abnormalities, such as uncontrolled diabetes, chronic kidney disease, grade II or above peripheral neuropathy (CTCAE V5.0), thyroid dysfunction, etc. 20) Severe infections that are active or poorly controlled clinically; 21) have not recovered from s
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;progression-free survival;Quality of life score;disease control rate; | — |
Countries
China
Contacts
Public ContactLei Han
Affiliated hospital of jining medical university
Outcome results
None listed