Hepatocellular carcinoma
Conditions
Interventions
Experimental group:Donafenib toluenesulfonic tablets, 200 mg BID po
camrelizumab, 3 mg/kg Q3W iv
cryoablation
Sponsors
The Fifth Medical Centre of the General Hospital of PLA
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Voluntarily join the group and sign a written informed consent; 2.Aged 18 to 80 years (including 80 years old), male or female; 3.Patients with hepatocellular carcinoma who are clinically diagnosed in accordance with the "Guidelines for the Diagnosis and Treatment of Primary Liver Cancer (2019 Edition)" or have been diagnosed by histology/cytology; 4.The subjects are not suitable for radical treatment through liver resection or the subjects are unwilling to choose liver resection for radical treatment for other reasons; 5.The subjects' lesions can be treated with cryoablation (the maximum diameter of the lesions is = 3 months; 10.Eastern Cooperative Oncology Group (ECOG) physical status (PS) score of 0-1; 11.Child-Pugh score= 90 g/L; 2)Absolute neutrophil count (ANC)>=1.5x10^9/L; 3)Platelet count >=50x10^9/L. (2)Blood biochemical examination (albumin was not used within 14 days before screening): 1)Albumin>=28 g/L; 2)Total bilirubin<=2xUpper limit of normal (ULN); 3)Aspartate aminotransferase (AST), alanine aminotransferase (ALT)<=5xULN; 4)Alkaline phosphatase (ALP) <=5xULN; 5)Creatinine<=1.5xULN. (3)Coagulation function: 1)International normalized ratio (INR) or prothrombin time (PT) <= 1.5xULN; 2)Activated partial thromboplastin time (APTT)<=1.5xULN.
Exclusion criteria
Exclusion criteria: 1.Previously diagnosed histologically/cytologically containing fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma and other components; 2.A history of malignancy, unless the following criteria are met: (1)The patient has received possible curative treatment and there is no evidence of the disease within 5 years; (2)Skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ and other carcinomas in situ who have successfully undergone resection. 3.Diffuse tumor lesions; 4.Tumor vascular invasion occurs in one or more of the following situations: (1)Portal vein tumor thrombus invades both the main portal vein and the first-order branch of the portal vein on the opposite side of the tumor; (2)Involving the superior mesenteric vein; (3)Involvement of the inferior vena cava. 5.Have a history of hepatic encephalopathy, hepatorenal syndrome, or a history of liver transplantation; 6.Pleural effusion, ascites, and pericardial effusion with clinical symptoms requiring drainage; 7.There is central system transfer; 8.A history of serious mental illness; 9.Suffering from diseases that affect the absorption, distribution, metabolism or clearance of the study drug (such as severe vomiting, chronic diarrhea, intestinal obstruction, malabsorption, etc.); Previous or concomitant medications/treatments: 10.Previously received allogeneic stem cell or solid organ transplantation; 11.Received sorafenib, lenvatinib, regorafenib and other anti-VEGF and/or VEGFR, RAF, MEK and other signaling pathway targeted therapy or anti-PD-1, anti-PD-L1, anti-PD-1 Treatment with immunomodulators such as CTLA-4; 12.Received other anti-tumor systemic therapy in the past, including traditional Chinese medicine with anti-tumor indications, less than 2 weeks after the completion of the treatment and before the drug in this study, or the adverse events caused by the preoperative treatment have not recovered to <= CTCAE grade 1 patients; toxicities from prior anticancer therapy excluding alopecia and grade 1/2 neurotoxicity due to oxaliplatin; 13.Concomitant use of drugs that may prolong QTc and/or induce torsades de pointes (Tdp) or drugs that affect drug metabolism; 14.Active or previously documented autoimmune disease or inflammatory disease (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.), patients with vitiligo or asthma that has been completely resolved in childhood, without any intervention in adulthood can be included; 15.Previously received allogeneic stem cell or solid organ transplantation; 16.Systemic immunosuppressive drug treatment has been used within 2 weeks before enrollment, or systemic immunosuppressive drug treatment is expected to be required during the study period, except for the following cases: (1)Intranasal, inhaled, topical or local injection (such as intra-articular injection) corticosteroids; (2)The dose does not exceed 10 mg/day of prednisone or other equivalent systemic corticosteroids; (3)Prophylactic use of corticosteroids for hypersensitivity reactions. 17.The patient is known or suspected to have a history of allergy to Donafenib or similar drugs, or a history of hypersensitivity reactions to chimeric or humanized antibodies
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Time to disease progression;Objective response rate;Disease control rate;Adverse event;Serious adverse event; | — |
Countries
China
Contacts
Public ContactYang Yongping
The Fifth Medical Centre of the General Hospital of PLA
Outcome results
None listed