hepatocellular carcinoma
Conditions
Interventions
Experimental group:Patients who met the inclusion criteria were treated with a combination of socazolimab (5mg/kg, d1, q21d), bevacizumab (7.5mg/kg, d1, q21d), and lenvatinib (body weight=60kg 12mg/da
Sponsors
Hubei Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Voluntarily participate in clinical research; fully understand this study and voluntarily sign the informed consent form; Willing to follow and able to complete all trial procedures; 2. Male or female, age >= 18 years; 3. Pathologically or clinically confirmed HCC; 4. Barcelona liver cancer stage (BCLC-C stage without extrahepatic metastasis, portal vein cancer thrombotype VP2/hepatic vein cancer thrombus/inferior vena cava partial cancer thrombus); 5. Child-Pugh liver function score 500 IU/mL or the lower limit of detection (only if the lower limit of detection of the trial center is higher than 500 IU/ml) but = 12 weeks.
Exclusion criteria
Exclusion criteria: 1. Pathologically confirmed to contain fiberplate-like HCC, sarcomatoid HCC, cholangiocarcinoma and other components; 2. Inferior vena cava cancer thrombosis involving the heart as suggested by imaging examination; 3. Evidence of significant coagulation disorder or other obvious bleeding risk: (1) History of intracranial hemorrhage or intraspinal hemorrhage; (2) Thrombotic or embolic events (except for asymptomatic and treatment-free intermuscular vein thrombosis) within 6 months before starting study treatment, or significant vascular disease (aortic aneurysm requiring surgical repair); (3) Esophageal and/or gastric varices within 6 months prior to starting study treatment Bleeding from tension; Presence of portal hypertension; Splenomegaly found by imaging examination, judged by the investigator or further gastroscopy to assess the risk of bleeding; (4) Use of anticoagulant therapy for therapeutic purposes (except low molecular weight heparin) within 2 weeks before starting study treatment; (5) Within 10 days before starting study treatment, use antiplatelet drugs, such as aspirin (> 325 mg/day), clopidogrel (> 75 mg/day), dipyridamole, ticlopidine or cilostazole, etc., or those who need long-term antiplatelet therapy; 4. Has received the following treatments or medications prior to initiation of study drug therapy: (1) Received radiotherapy to non-target lesion sites within 2 weeks before starting study drug treatment; (2) Received nitrosourea, mitomycin C within 6 weeks before starting study drug treatment; (3) Systemic use of glucocorticoids (prednisone > 10 mg/day or equivalent dose of similar drugs) or other immunosuppressive agents within 14 days before starting study drug treatment; The following conditions are excluded: treatment with topical, ocular, intraarticular, intranasal, and inhaled glucocorticoids; short-term use of glucocorticoids for prophylactic treatment (e.g., prevention of vomiting caused by oxaliplatin, contrast allergy); (4) Vaccination with live attenuated vaccines within 4 weeks before starting study drug treatment; 5. Inability to undergo enhanced imaging examination (CT or MRI) for any reason; 6. Subjects with active, or previously suffered autoimmune diseases that may recur (such as systemic lupus erythematosus, rheumatoid arthritis, vasculitis, etc.), except for clinically stable autoimmune thyroid disease type I diabetes mellitus; 7. Within 5 years before starting study drug treatment, have had other active malignancies, except for malignancies that can be treated locally and have been cured (such as basal cell or squamous cell carcinoma of the skin, superficial or non-invasive bladder cancer, carcinoma in situ of the cervix, intraductal carcinoma in situ of the breast, papillary thyroid carcinoma).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR);Conversion success rate;Surgical completion rate;Overall Survival (OS);Progression-free Survival (PFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease-free survival (DFS);Disease Control Rate (DCR); | — |
Countries
China
Contacts
Public ContactTao Yin
Hubei Cancer Hospital
Outcome results
None listed