Unresectable hepatocellular carcinoma judged by the AASLD-2010 practice guideline standard
Conditions
Interventions
Experimental group:Cadonilimab combined with HAIC and SBRT
Sponsors
Hunan Provincial People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Sign a written informed consent before the implementation of any trial-related procedures; 2.Male or female: >= 18 years old, = 5cm; Satellite foci (limited to one liver lobe/more than one liver lobe = 1.5×10^9/L; platelet count (PLT) >= 75× 10^9 /L; The hemoglobin content (HGB) is >= 9.0 g/dL; Liver function: Serum total bilirubin (TBIL) = 28 g/L; Renal function: Serum creatinine (Cr) = 50mL/min (Cockcroft-Gault formula); The results of the urine routine test show that urine protein 2+ For patients whose urine routine test at baseline showed urine protein >= 2+, 24-hour urine collection and 24-hour urine protein quantification should be performed. 1g; Coagulation function: The international normalized ratio (INR) and the activated partial thromboplastin time (APTT) are <= 1.5 times ULN; 13.For female subjects of childbearing age, a urine or serum pregnancy test should be received within 3 days before the first administration of the study drug (Day 1 of Cycle 1), and the result should be negative. If the result of the urine pregnancy test cannot be confirmed as negative, a blood pregnancy test is required. Women of non-reproductive age are defined as those who have been menopausal for at least one year, or have undergone surgical sterilization or hysterectomy. If there is a risk of conception, all subjects (whether male or female) are required to adopt contraceptive measures with an annual failure rate of less than 1% throughout the treatment period until 120 days after the administration of the last study drug (or 180 days after the administration of the last chemotherapy drug). Contraceptive measures with a rate lower than 1%.
Exclusion criteria
Exclusion criteria: 1.Previously confirmed histological/cytological components containing fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma, etc; 2.There is a history of hepatic encephalopathy or liver transplantation; 3.Pleural effusion, ascites and pericardial effusion with clinical symptoms that require drainage; 4.Patients with acute or chronic active hepatitis B or C, hepatitis B virus (HBV) DNA >2000IU/ml or 104 copies /ml; Hepatitis C virus (HCV) RNA > 103 copies /ml; Hepatitis B surface antigen Both HbsAg and anti-HCV antibodies are positive simultaneously; 5.There is metastasis in the central nervous system; 6.There has been an event of esophageal or gastric fundus variceal bleeding caused by portal hypertension within the past 6 months. 7.Any life-threatening bleeding events that occurred within the past 3 months, including those requiring blood transfusion treatment, surgery or local treatment, or continuous medication; 8.Thromboembolic events of arteries and veins within the past 6 months, including myocardial infarction, unstable angina pectoris, and cerebrovascular accident Or a history of transient ischemic attack, pulmonary embolism, deep vein thrombosis or any other severe thromboembolism. plant Venous port or catheter-derived thrombosis, or superficial venous thrombosis, after conventional anticoagulant therapyExcept for those with stable plugs. Prophylactic use of small doses of low-molecular-weight heparin (such as enoxaparin 40 mg/ day) is permitted. 9.Branches of the portal vein, or simultaneous involvement of the superior mesenteric vein. Inferior vena cava tumor thrombus; 10.Within 2 weeks before the first administration, use aspirin (> 325 mg/ day) or other known drugs that can inhibit blood for 10 consecutive days Drugs with small plate functions such as dipyridamole or clopidogrel, etc; 11.Uncontrolled hypertension, with a systolic blood pressure greater than 150mmHg or a diastolic blood pressure greater than 90 mmHg after the best medical treatment, is considered hypertension History of crisis or hypertensive encephalopathy; 12.Symptomatic congestive heart failure (New York Heart Association Classification II-IV). Symptomatic or poorly controlled heart rhythm Abnormal. A history of congenital long QT syndrome or corrected QTc > 500ms during screening (measured using the Fridericia method) Calculate; 13.Severe bleeding tendency or coagulation dysfunction, or currently undergoing thrombolytic therapy; 14.A history of gastrointestinal perforation and/or fistula within the past 6 months, and a history of intestinal obstruction (including incomplete parenteral nutrition required)Intestinal obstruction, extensive intestinal resection (partial colectomy or extensive small intestinal resection with chronic diarrhea), Crohn's diseaseIllness, ulcerative colitis or long-term chronic diarrhea; 15.Received radiotherapy within 3 weeks before the first administration. For patients who received radiotherapy three weeks before the first administration, it is necessaryAll of the following conditions must be met to be included in the group: There are no radiotherapy-related toxic reactions at present, and no sugar intake is required Corticosteroids are used to rule out radiation pneumonitis, radiation hepatitis, radiation enteritis, etc; 16.Those with a history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, drug-related pneumonia, severely impaired lung function, et
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| The tumor necrosis rate is >= 50%;Surgical conversion rate;Overall survival;Pathological complete response rate;Progression-Free Survival;Time to Progression;Adverse events; | — |
Countries
China
Contacts
Public ContactLiu Sulai
Hunan Provincial People's Hospital
Outcome results
None listed