Advanced unresectable hepatic cell carcinoma
Conditions
Interventions
Experimental group:Treat according to the treatment plan
Sponsors
Huizhou Central People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Prior to the implementation of any test related procedures, sign a written informed consent; 2. Aged 18-70 years, no gender limit; 3. ECOG PS score is 0-1; 4. Barcelona Clinic Liver Cancer (BCLC) stage C and stage B, which is not suitable for radical surgery; 5. Never received systemic antitumor therapy for hepatocellular carcinoma; 6. Child-Pugh grade A~B (score 3 months; 8. At least one measurable lesion according to RECIST 1.1 criteria; 9. Total triiodothyronine (T3) or free T3 and free thyroxine (T4) were within normal ranges. (can be controlled with thyroid replacement therapy). Subjects with asymptomatic T3, free T3 or abnormal T4 can be enrolled; 10. Adequately control blood pressure; 11. Adequate organ function, subject shall meet the following laboratory criteria: (1) The absolute value of neutrophil granulocyte (ANC) >=1.5x10^9/L in the last 14 days without the use of granulocyte colony stimulating factor; (2) Platelets >=100x10^9/L without blood transfusion in the last 14 days; (3) Hemoglobin >9g/dL in the last 14 days without blood transfusion or erythropoietin use; (4) Serum creatinine =60 ml/min; (5) Good coagulation function, defined as International standardized ratio (INR) or prothrombin time (PT) <=1.5 times ULN; (6) Normal thyroid function, defined as thyroid stimulating hormone (TSH) within the normal range. Subjects with total T3 (or FT3) and FT4 within the normal range may be enrolled if baseline TSH is outside the normal range; 12. For female subjects of childbearing age, a negative urine or serum pregnancy test should be administered within 3 days prior to the first study drug administration (day 1 of Cycle 1). If the urine pregnancy test results cannot be confirmed as negative, a blood pregnancy test is requested. Non-childbearing women were defined as at least one year after menopause or having undergone surgical sterilization or hysterectomy; If there is a risk of conception, all subjects (male or female) are required to use contraception with an annual failure rate of less than 1% for the entire duration of treatment up to 120 days after the last study drug administration (or 180 days after the last chemotherapy drug administration).
Exclusion criteria
Exclusion criteria: 1. Fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma and other components previously confirmed by histology/cytology; 2. Have a history of hepatic encephalopathy or liver transplantation; 3. Tumor lesions accounted for more than 50% of the liver volume; 4. Hepatitis B virus (HBV) DNA > 1*10^4 copies /ml in patients with acute or chronic active hepatitis B or hepatitis C; Hepatitis C virus (HCV) RNA > 10^3 copies /ml; Hepatitis B surface antigen (HbsAg) and anti-HCV antibody positive; 5. Central nervous system metastasis; 6. Any life-threatening bleeding event within the previous 3 months, including the need for transfusion therapy, surgery or local therapy, continuous medication; 7. History of arteriovenous thromboembolism events within the past 6 months, including myocardial infarction, unstable angina, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis, or any other severe thromboembolism. Implantable intravenous port or catheter-derived thrombosis, or superficial venous thrombosis, except in patients with stable thrombosis after conventional anticoagulant therapy. Allow prophylactic use of low-dose low molecular weight heparin (e.g., enoxaparin 40 mg/ day); 8. Portal vein branch cancer thrombus involved the main portal vein or the superior mesenteric vein at the same time; Inferior vena cava carcinoma thrombus; 9. Aspirin (> 325 mg/ day) or other drugs known to inhibit platelet function, such as dipyridamole or clopidogrel, were used for 10 consecutive days within 2 weeks prior to initial administration; 10. Symptomatic congestive heart failure (New York Heart Association Grade II-IV); Symptomatic or poorly controlled arrhythmias; Adjusted QTc > 500ms for congenital long QT syndrome history or screening (calculated using the Fridericia method); 11. Severe bleeding tendency or coagulopathy, or receiving thrombolytic therapy; 12. A previous 6-month history of gastrointestinal perforation and/or fistula, a history of intestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), extensive enterotomy (partial resection of the colon or extensive resection of the small intestine with chronic diarrhea), Crohn's disease, ulcerative colitis, or long-term chronic diarrhea; 13. Received radiation therapy within 3 weeks prior to initial administration. Patients who received radiation therapy three weeks before the first dose must meet all of the following conditions to be enrolled: no radiotherapy-related toxicity, no need to take glucocorticoids, exclusion of radiation pneumonia, radiation hepatitis, radiation enteritis, etc.; 14. Patients with active tuberculosis (TB) who are receiving anti-TB therapy or have received anti-TB therapy within 1 year prior to initial drug administration; 15. Patients infected with human immunodeficiency virus (HIV 1/2 antibody positive), known persons infected with syphilis; 16. Severe infections that are active or clinically poorly controlled. Severe infection, including but not limited to hospitalization due to complications of infection, bacteremia, or severe pneumonia, within 4 weeks prior to initial dosing; 17. An active autoimmune immune disease requiring systemic therapy (e.g., disease-modifying drugs, corticosteroids or immunosuppressants) occurred within two years prior to initial administration. Alternative therapies (such as thyroxine, insulin, or physical co
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR) assessed by RECIST 1.1; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR) assessed by mRECIST;Disease control rates (DCR) assessed by mRECIST and RECIST 1.1;Sustained response rates (DOR) assessed by mRECIST and RECIST 1.1;Safety;Overall survival (OS); | — |
Countries
China
Contacts
Public ContactYuan Xia
Outcome results
None listed