Hepatocellular carcinoma
Conditions
Interventions
Group A:Combination therapy of Donafenib, PD-1 monoclonal antibody and hepatic arterial infusion chemotherapy
Group B:Combination therapy of Donafenib and PD-1 monoclonal antibody
Sponsors
Fujian Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Voluntary enrollment and signing of written informed consent form; 2. Age: 18 to 75 years old (inclusive), gender not limited; 3. Patients with hepatocellular carcinoma who have been clinically diagnosed in accordance with the "Diagnosis and Treatment Guidelines for Primary Liver Cancer (2024 Edition)" or have been confirmed by histology/cytology, with CNLC stage II-III, and are not suitable for or refuse surgical operation, liver transplantation and ablation treatment; 4. Has not received systematic treatment; 5. The end time of the last TACE, radiotherapy and ablation treatment was more than 4 weeks; 6. Patients who have undergone hepatectomy in the past should have undergone R0 resection, and tumor recurrence should have occurred more than 24 months after the operation. 7. There is at least one evaluable lesion (RECIST 1.1 standard); 8. Expected survival time >=3 months; 9. The physical condition (PS) score of the Eastern Cancer Collaboration Group (ECOG) was 0 to 1 point. 10.Child-Pugh score =90 g/L; e) Absolute neutrophil count (ANC) >=1.5×10^9/L; f) Platelet count ==×10^9/L; Blood biochemical test (no albumin used within 14 days before screening) : j) Albumin >=28 g/L; k) Total bilirubin <=2× upper limit of normal value (ULN); 1) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <=5×ULN; m) Alkaline phosphatase (ALP) <=5×ULN; n) Creatinine = 1.5×ULN; Coagulation function o) International normalized ratio (INR) or prothrombin time (PT) <=1.5×ULN; Activated partial thromboplastin time (APTT) is less than or equal to 1.5×ULN
Exclusion criteria
Exclusion criteria: Previous or combined diseases: 1. Previously histologically/cytologically confirmed components such as fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, and cholangiocarcinoma; 2. Have a history of malignant tumors other than hepatocellular carcinoma, unless the following criteria are met: a) The patient has received possible curative treatment and there is no evidence of the existence of the disease within 5 years; b) Successfully received resected cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ and other carcinomas in situ; 3. Diffuse tumor lesions; 4. Have a history of hepatic encephalopathy, hepatorenal syndrome, or liver transplantation; 5. Pleural effusion, ascites and pericardial effusion with clinical symptoms requiring drainage; 6. There is central system metastasis; 7. Have a history of severe mental illness in the past; 8. Suffering from diseases that affect the absorption, distribution, metabolism or clearance of the studied drugs (such as severe vomiting, chronic diarrhea, intestinal obstruction, absorption disorders, etc.); Previous or combined medication/treatment: 9. Previously received targeted therapy against VEGF and/or VEGFR, RAF, MEK and other signaling pathways such as sorafenib, lenvatinib, regorafenib, or immunomodulator therapy against PD-1, PD-L1, CTLA-4, etc. 10. Previously received hepatic artery infusion chemotherapy; 11. Taking drugs that may prolong QTc and/or induce tortuous ventricular tachycardia at the tip (Tdp) or affect drug metabolism simultaneously; 12. Have a history or currently suffer from congenital or acquired immune deficiency diseases; 13. Active or previously recorded autoimmune or inflammatory diseases (including but not limited to: Autoimmune hepatitis, interstitial pneumonia, inflammatory bowel disease, systemic lupus erythematosus, vasculitis, uveitis, hypophysitis, hyperthyroidism or hypothyroidism, asthma requiring bronchodilator treatment, etc., those with vitiligo or asthma that has been completely relieved in childhood and do not require any intervention in adulthood can be included. 14. Has received allogeneic stem cell or parenchymal organ transplantation in the past; 15. Systemic immunosuppressive drug treatment was used within 2 weeks before enrollment, or systemic immunosuppressive drug treatment was expected during the study period, except for the following situations: 16. Intranasal, inhaled, topical or local injection (such as intra-articular injection) corticosteroids; 17. Prednisone or other systemic corticosteroids with equivalent effects at a dose not exceeding 10 mg per day; 18. Prophylactic use of corticosteroids for hypersensitivity reactions; Safety 19. Patients who are known or suspected of having a history of allergy to donafenib or similar drugs, or have a history of hypersensitivity to chimeric or humanized antibodies or fusion proteins, or are allergic to excipients of the study drug; 20. There is active bleeding or abnormal coagulation function, with a bleeding tendency or currently undergoing thrombolytic, anticoagulant or antiplatelet therapy; 21. There have been thrombotic or thromboembolic events within the past 6 months, such as stroke and/or transient ischemic attack, deep vein thrombosis, pulmonary embolism, etc. 22. There has been a bleeding event of esophageal or gastric varices caused by portal hypertension within the past 6 months, or any life-threa
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Progression free survival; | — |
Countries
China
Contacts
Public ContactZhuting Fang
Fujian Cancer Hospital
Outcome results
None listed