advanced hepatocarcinoma
Conditions
Interventions
Experimental group:TACE + anlotinib and TQB-2450
Sponsors
Henan Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Advanced hepatocellular carcinoma, child-pugh =3 months; 5. Without molecular targeted drug therapy and immunotherapy; 6. Have adequate organ and bone marrow functions, that is, meet the following criteria: (1) Blood routine examination standards meet: 1) Absolute value of neutrophils (ANC) >=1.5x10^9/L without the use of granulocyte colony-stimulating factor in the last 14 days; 2) Platelets >=90×10^9/L in the last 14 days without blood transfusion; 3) Hemoglobin >9g/dL in the absence of blood transfusion or erythropoietin in the last 14 days; (2) Biochemical tests shall meet the following standards: 1) Total bilirubin =60ml/min (Cockcroft-Gault formula); (3) Good coagulation function, defined as international standardized ratio (INR) or prothrombin time (PT) <=1.5 TIMES ULN; (4) Normal thyroid function, defined as thyroid stimulating hormone (TSH) within the normal range. If the baseline TSH is outside the normal range, subjects with total T3 (or FT3) and FT4 within the normal range may be enrolled; (5) The myocardial enzyme profile is within the normal range (if the investigator comprehensively determines that the simple laboratory abnormality is not clinically significant, it is allowed to be included in the group); 7. Women of childbearing age should agree to use contraceptive methods (such as iUDS, birth control pills or condoms) during the study period and for a period of 6 months after the study ends; A negative serum or urine pregnancy test within the 7 days prior to study enrollment must be non-lactating or demonstrate no risk of pregnancy by meeting one of the following criteria: (1) Postmenopause was defined as age greater 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 who have amenorrhea for 12 months or more after discontinuing all exogenous hormone therapy and whose luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels are within the laboratory postmenopausal reference range may also be considered postmenopausal; (3) has undergone irreversible sterilization, including hysterectomy, bilateral ovariectomy or bilateral salpingectomy, except bilateral tubal ligation; 8. Men should consent to use contraception during the study period and for six months after the study period ends; 9. Patients voluntarily joined the study and signed informed consent with good compliance.
Exclusion criteria
Exclusion criteria: 1. Other malignant diseases outside the biliary tract diagnosed within 5 years prior to first administration (excluding radical basal cell carcinoma of the skin, squamous carcinoma of the skin, and/or radically resected carcinoma in situ); 2. Ampullary tumor; 3. Are currently participating in an interventional clinical study or have been treated with another study drug or study device within 4 weeks prior to initial dosing; 4. Patients who have previously been treated with vegFR-target inhibitor drugs, including androtinib hydrochloride capsules, or other PD-1/PD-L1/ CTLA-4 antibody therapy or other immunotherapy targeting PD-1/PD-L1/ CTLA-4, or received TACE within 4 weeks; 5. Prior palliative radiotherapy for biliary tract tumors, except postoperative adjuvant radiotherapy; 6. Received systemic systemic therapy with anti-tumor indications of Proprietary Chinese medicines or immunomodulatory drugs (including thymosin, interferon, and interleukin, except for local use to control pleural effusion) within 2 weeks before the first administration; 7. An active autoimmune disease requiring systemic treatment (e.g., palliative drugs, glucocorticoids, or immunosuppressants) occurred within 2 years prior to first dosing. Alternative therapies (such as thyroxine, insulin, or physiologic glucocorticoids for adrenal or pituitary insufficiency) are not considered systemic. Known history of primary immunodeficiency. Patients with only positive autoimmune antibodies need to confirm whether there is an autoimmune disease according to the judgment of the researcher; 8. The study was receiving systemic glucocorticoid therapy (excluding nasal spray, inhalation, or other topical glucocorticoid) or any other form of immunosuppressive therapy within 4 weeks prior to initial administration. Note: Physiological doses of glucocorticoid (<=10 mg/ day of prednisone or equivalent) were permitted; 9. There is clinically uncontrollable pleural effusion/abdominal effusion (patients who do not need drainage effusion or who stop drainage for 3 days without a significant increase in effusion can be included in the group); 10. Allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation is known; 11. Known allergy to the active ingredient or excipient of antiotinib and TQB2450; 12. Absolute contraindications to TACE. (1) Severe liver dysfunction, including severe jaundice, hepatic encephalopathy, refractory ascites, or hepatorenal syndrome; (2) Severe decline in coagulation function that cannot be corrected; (3) The main portal vein was completely embolized by cancer thrombus, the formation of collateral vessels was less, and the portal vein stent could not be used to restore the main portal vein to the liver; (4) With active hepatitis or severe infection and can not be treated at the same time; (5) Severe iodine contrast agent allergy. 13. Liver function Child-Pugh GRADE C; 14. Not fully recovered from toxicity and/or complications associated with any intervention (i.e., <= grade 1 or baseline, excluding fatigue or hair loss) before initiation of treatment; 15. A known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1/2 antibody positive); 16. Untreated active hepatitis B (defined as HBsAg positive with HBV-DNA copy number greater than the upper limit of the normal value in the laboratory department of the research center); Note: hepat
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-Free Survival;Overall survival;Safety; | — |
Countries
China
Contacts
Public ContactHailiang Li
Henan Cancer Hospital
Outcome results
None listed