Hepatocellular Carcinoma
Conditions
Interventions
Cardonilizumab test group:Cardonilizumab
Sponsors
The First Affiliated Hospital of Army Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Written informed consent must be signed before any trial-related procedures are implemented; 2. Male or female aged >=18 and 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) within normal range (Thyroid replacement therapy can be accepted to achieve this). Asymptomatic subjects with abnormal T3, free T3, or free T4 can be included; 10. Routine gastroscopy to assess esophageal gastric varices and bleeding risk; 11. Sufficient organ and bone marrow function, with laboratory values meeting the following requirements within 7 days prior to randomization (it is not allowed to meet these conditions by administering any blood components, cell growth factors, albumin, or other corrective treatment drugs within 14 days before the laboratory exam), specifically: 1. Blood count indicators (1) Absolute neutrophil count (ANC) >=1.5×10?/L (2) Platelet count (PLT) >=50×10?/L (3) Hemoglobin (HGB) >=9.0 g/dL 2. Liver function indicators (1) Serum total bilirubin (TBIL) =28 g/L 3. Kidney function indicators (1) Serum creatinine (Cr) =50 ml/min (calculated using the Cockcroft-Gault formula) (3) Urinalysis results show urine protein =2, 24-hour urine protein quantification must be <1g 4. Coagulation function indicators (1) International normalized ratio (INR) <=1.5×ULN (2) Activated partial thromboplastin time (APTT) <=1.5×ULN 12. For female participants of childbearing age, a urine or serum pregnancy test must be conducted within 3 days prior to the first administration of the study drug (Day 1 of Cycle 1), and the result must be negative. If the urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is required. Women not of childbearing age are defined as having been postmenopausal for at least 1 year or having undergone surgical sterilization or hysterectomy; if there is a risk of pregnancy, all subjects (male or female) must use contraceptive measures with an annual failure rate of less than 1% throughout the treatment period until 120 days after the last administration of the study drug (or 180 days after the last administration of chemotherapy).
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. Esophageal or fundus variceal bleeding events caused by portal hypertension have occurred in the past 6 months. Severe (G3) varicose veins were known to be present on endoscopy within 3 months prior to first administration. There was evidence of portal hypertension (including splenomegaly on imaging) and a high risk of bleeding as assessed by the investigator. 4. Any life-threatening bleeding event within the past 3 months, including the need for blood transfusion treatment, surgery or local treatment, and ongoing medication. 5. History of arteriovenous thromboembolism events within the past 6 months, including myocardial infarction, unstable angina pectoris, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis, or any other severe thromboembolism. 6. The main portal vein cancer thrombus involves both the portal vein branch or the superior mesenteric vein. 7.Uncontrolled hypertension, systolic blood pressure > 150mmHg or diastolic blood pressure > 90 mmHg after optimal medical treatment, history of hypertensive crisis or hypertensive encephalopathy. 8. Severe bleeding tendency or clotting dysfunction, or being treated with thrombolysis. 9. Previous history of gastrointestinal perforation and/or fistula within the last 6 months, history of intestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), extensive enterectomy (partial colectomy or extensive enterectomy with chronic diarrhea), Crohn's disease, ulcerative colitis, or long-term chronic diarrhea. 10.Previous or current history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, drug-related pneumonia, severe impairment of lung function and other lung diseases. 11. Severe infections that are active or poorly controlled clinically. Severe infection, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia, in the 4 weeks prior to initial dosing. 12. An active autoimmune disease requiring systemic treatment (e.g. with disease-modifying drugs, corticosteroids, or immunosuppressants) occurred within 2 years prior to first administration. 13. Major surgical procedures (craniotomy, thoracotomy, or laparotomy) or unhealed wounds, ulcers, or fractures within 4 weeks prior to initial dosing. 13. A biopsy or other minor surgical procedure was performed within 7 days prior to the initial dosing, except for venipuncture for the purpose of IV infusion. 14. Received Chinese medicines with anti-tumor indications or immunomodulatory effects (including thymosin, interferon, interleukin, except for topical use to control pleural effusion or ascites) within 2 weeks prior to initial dosing. 15. Uncontrolled/uncorrectable metabolic disorders or other non-malignant organ diseases or systemic diseases or cancer secondary reactions that can lead to higher medical risk and/or uncertainty in the evaluation of survival. 16. Have previously received any anti-PD-1 antibodies, anti-PD-L1 /L2 antibodies, anti-CTLA4 antibodies, or other immunotherapy. Previously received targeted therapy against VEGF and/or VEGFR, RAF, MEK, PDGFR, FGFR and other signaling pathways. 17. Known to be allergic to any ingredients of cardonil
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective relief rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Security; | — |
Countries
China
Contacts
Public ContactKai Feng
The First Affiliated Hospital of Army Medical University
Outcome results
None listed