hepatocellular carcinoma
Conditions
Interventions
Experimental group:Cadonilimab (10mg/kg Q3W D1)+Anti-angiogenic target therapy (first-line)
Sponsors
Eastern Hepatobiliary Surgery Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Age 18-75 years old, male or female 2) Hepatocellular carcinoma was first diagnosed according to the diagnostic criteria of the Chinese Code of Diagnosis and Treatment for Primary Liver Cancer (2022 edition). 3) Patients who progressed on previously received target-immunized combined systemic anti-tumor therapy for hepatocellular carcinoma or were intolerant 4) At least 1 measurable lesion according to RECIST1.1 criteria. 5) Child-Pugh grade A or Grade B improves to grade A with aggressive medical treatment. 6) Renal function and cardiopulmonary function were basically normal. Hemoglobin = 90g/L, white blood cell count = 3.0×10^9/L, neutrophil count = 1.5×10^9/L, platelet count = 75×10^9/L 7) There is no history of previous radiotherapy or the location of the re-radiotherapy does not coincide with the original radiotherapy site 8) All acute toxicities from prior antineoplastic therapy have resolved to Grade 0-1 (per NCI CTCAE version 5.0) or to acceptable levels for inclusion/exclusion criteria 9) Total triiodothyronine (T3) or free T3 and free thyroxine (T4) are within the normal range (can be controlled by thyroid replacement therapy). Subjects with asymptomatic T3, free T3, or free T4 abnormalities may be enrolled. 10) Adequate blood pressure control.
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) There are clinical symptoms requiring drainage of pleural fluid, ascites and pericardial effusion. 4) Subject with acute or chronic active hepatitis B or hepatitis C, hepatitis B virus (HBV) DNA > 2000IU/ml or 10^4 copies /ml; Hepatitis C virus (HCV) RNA > 10^3 copies /ml; Hepatitis B surface antigen (HbsAg) and anti-HCV antibodies were both positive. 5) Central nervous system metastasis. 6) Bleeding events of esophageal or gastric varices caused by portal hypertension occurred within the past 6 months. Severe (G3) varicose veins were known to be present on endoscopy within 3 months prior to first administration. Subjects with evidence of portal hypertension (including splenomegaly on imaging) who were at high risk of bleeding as assessed by the investigator. 7) Any life-threatening bleeding event within the previous 3 months, including the need for blood transfusion treatment, surgery or local treatment, and ongoing medication. 8) 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. Implantable intravenous infusion port or catheter-derived thrombosis, or superficial venous thrombosis, except in cases where the thrombus has stabilized after conventional anticoagulant therapy. Prophylactic use of small doses of low molecular weight heparin (e.g., enoxaparin 40 mg/ day) is permitted. 9) Portal vein trunk cancer thrombus also involves the portal vein branches, or the superior mesenteric vein. Inferior vena cava cancer thrombus 10) Use aspirin (> 325 mg/ day) or other drugs known to inhibit platelet function, such as dipyridamole or clopidogrel, for 10 days within 2 weeks of initial administration. 11) Uncontrolled hypertension, systolic blood pressure > 150 mmHg or diastolic blood pressure > 90 mmHg after optimal medical treatment, history of hypertensive crisis or hypertensive encephalopathy 12) Symptomatic congestive heart failure (New York Heart Association Grade II-IV). Symptomatic or poorly controlled arrhythmia. QTc > 500ms corrected for congenital long QT syndrome history or screening (calculated using the Fridericia method). 13) Severe bleeding tendency or receiving thrombolytic therapy. 14) A previous history of gastrointestinal perforation and/or fistula within the last 6 months, a 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. 15) Other acute or chronic illnesses, psychiatric disorders, or abnormalities in laboratory test values that may increase the risk associated with study participation or study drug administration, or interfere with the interpretation of study results, and, in the investigator's judgment, classify subjects as ineligible to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate;Duration of response; | — |
Secondary
| Measure | Time frame |
|---|---|
| progression free survival;disease control rate;overall survival;Adverse events; | — |
Countries
China
Contacts
Public ContactHaibin Zhang
Eastern Hepatobiliary Surgery Hospital
Outcome results
None listed