hepatocellular carcinoma
Conditions
Interventions
Experimental group:Thermal ablation combined with ramvaratinib mesylate
Control group:Thermal ablation
Sponsors
The Fifth Medical Center of PLA General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. The patients voluntarily joined the study and signed the informed consent with good compliance and follow-up; 2. No gender limit, patients aged 18-75 years; 3. Patients with unresectable early and middle stage hepatocellular carcinoma confirmed by histopathology, imaging diagnosis or cytology, with liver function Child-Pugh score = 3.0cm but =1cm accurately measured by MRI or CT enhancement according to mRECIST standards, and the target lesion had not received local treatment (including but not limited to radiofrequency ablation, argon helium knife, radiotherapy and other local treatments); 6. Life expectancy of at least 3 months; 7. ECOG (Eastern Oncology Consortium) score: 0-1; 8. Major organ functions within 7 days prior to treatment shall meet the following criteria: (1) The standard of blood routine examination shall be met (no blood transfusion or blood products within 14 days, no correction by G-CSF and other hematopoietic stimulating factors) : 1) Hemoglobin (HB) >=90g/L; 2) Neutrophil absolute value (ANC) >=1.5x10^9/L; 3) Leukocyte (WBC) >=3.0x10^9/L; 4) Platelet (PLT) >=70x10^9/L; (2) Biochemical examination shall meet the following standards: 1) Total bilirubin (TBIL) =60ml/min; (3) Doppler ultrasound evaluation: left ventricular ejection fraction (LVEF) >= the lower limit of normal value (50%); 8. Women of childbearing age should take appropriate contraceptive measures and should not breastfeed for 3 months from screening to cessation of study treatment. A pregnancy test is negative or one of the following criteria is met to demonstrate that there is no risk of pregnancy before starting administration: (1) Postmenopause was defined as being older than 50 years and amenorrhea for at least 12 months after cessation of all exogenous hormone replacement therapy; (2) Women younger than 50 years of age may also be considered postmenopausal if they are 12 months or more after cessation of all exogenous hormone therapy and if luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels are within the laboratory postmenopausal reference range; (3) Had undergone irreversible sterilization, including hysterectomy, bilateral ovariectomy or bilateral tubal resection, except bilateral tubal ligation; For men, consent was required to use an appropriate method of contraception or to have been surgically sterilized during the trial period and 8 weeks after the last administration of the trial drug. 9. Patients who have no indications for radical surgery or are unwilling to receive surgical treatment, or patients who cannot undergo liver transplantation.
Exclusion criteria
Exclusion criteria: 1. Severe dysfunction of heart, lung and kidney function; 2. Patients planning liver transplantation; 3. Present or present with other malignancies within 5 years, except cured cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumors [Ta (non-invasive tumors), Tis (carcinoma in situ), and T1 (tumor infiltrating basal membrane)]; 4. Unmitigated toxic reactions that are at least grade 1 above CTCAE(4.0) due to any previous treatment; 5. Patients with multiple factors affecting oral medication (such as inability to swallow, chronic diarrhea, etc.); 6. Accompanied by pleural effusion or ascites, causing respiratory syndrome (>=CTCAE grade 2 dyspnea); 7. Esophageal (gastric fundus) varices burst and bleed within 1 month before treatment; 8. Symptoms and signs associated with interstitial diseases; 9. Patients with any severe and/or uncontrolled medical condition, including: (1) Patients with hypertension (systolic blood pressure >=150 mmHg, diastolic blood pressure >=100 MMHG) who cannot be well controlled by single antihypertensive medication; Or use two or more antihypertensive drugs to control blood pressure; (2) Patients with grade I or above myocardial ischemia or myocardial infarction, arrhythmias (including QTc>=480ms), and >= grade 2 congestive heart failure (New York Heart Association (NYHA) grades); (3) Active or uncontrolled severe infection (>=CTCAE grade 2 infection); (4) Renal failure requiring hemodialysis or peritoneal dialysis; (5) A history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; (6) Poor blood glucose control in diabetic patients (fasting blood glucose (FBG) > 10mmol/L); (7) Urine routine indicated urine protein >=++, and confirmed 24 hours urine protein quantity > 1.0 g; (8) Abnormal coagulation function (INR >1.5 or prothrombin time (PT) > ULN+4 seconds or APTT >1.5 ULN), bleeding tendency or receiving thrombolytic or anticoagulant therapy; Note: Under the premise of INR =CTCAE grade 3 during the first 4 weeks of enrollment; 14. Patients who have a history of psychotropic substance abuse and are unable to abstain or have mental disorders; 15. Patients who have had or currently have any brain metastases; 16. Participated in clinical trials of other antitumor drugs within four weeks; 17. Patients allergic to ranvastinib mesylate; 18. Patients with complete embolization of the main portal vein by cancer thrombus; 19. Concomitants that, in the judgment of the investigator, seriously endanger the safety of the patient or affect the patient's completion of the study; 20. Patients who had previously received anti-tumor t
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tumor recurrence time; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Objective response rate;Safety; | — |
Countries
China
Contacts
Public ContactXie Hui
Outcome results
None listed