HCC
Conditions
Interventions
Experimental group:regorafenib and cadonilimab
Sponsors
Department of Oncology, Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Sign the informed consent form 2. Age 18-75 years 3. Locally advanced or metastatic and/or unresectable HCC, with diagnosis confirmed by histology/cytology 4. Disease progression after first-line systemic therapy 5. At least one measurable lesion (measurable according to RECIST 1.1) that has not been previously treated 6. Patients who have received prior local treatments (e.g., radiofrequency ablation, anhydrous ethanol or acetic acid injection, cryoablation, high-intensity focused ultrasound, transarterial chemoembolization, transarterial embolization, etc.) are also eligible if the target lesion has not undergone prior local treatment or if there is subsequent progression of a target lesion within the area of prior local treatment according to RECIST v1.1 7. ECOG performance status score of 0 or 1; 8. Child-Pugh class A or B7; 9. Adequate hematologic and organ function based on the following laboratory test results obtained within 14 days prior to the start of study treatment (unless otherwise specified): (1) ANC >= 1.5×10^9/L (1500/L), without granulocyte colony-stimulating factor support; (2) Platelet count >= 75×10^9/L (75,000/L), without transfusion; (3) Hemoglobin >= 90 g/L (9 g/dL); 10. Blood transfusion is allowed for the patient to meet this criterion; (1) AST, ALT, and alkaline phosphatase (ALP) = 50 mL/min (calculated using the Cockcroft-Gault formula); (4) Serum albumin >= 28 g/L (2.8 g/dL); (5) Patients not receiving anticoagulant therapy: INR or aPTT = 2 should collect a 24-hour urine sample, and it must be confirmed that 24-hour urine protein content is < 1 g; 11. Negative HIV test result at screening; 12. Documented hepatitis virology status confirmed by HBV and HCV serology tests; 13. Patients with active hepatitis B virus (HBV) infection: HBV DNA < 500 IU/mL obtained within 28 days prior to the start of study treatment, and at least 14 days of anti-HBV therapy (according to local standard treatment, e.g., entecavir) before study enrollment, and willing to continue treatment during the study.
Exclusion criteria
Exclusion criteria: 1. Known history of primary immunodeficiency; 2. Known to have active tuberculosis; 3. Known history of allogeneic organ transplantation and hematopoietic stem cell transplantation; 4. Known history of human immunodeficiency virus (HIV) infection (i.e. HIV antibody positive); 5. Has experienced severe allergic reactions to humanized antibodies or fusion proteins; 6. Known to have hypersensitivity reactions to any component of regorafenib or candenizumab formulations; 7. Individuals with pre-existing severe heart disease, including congestive heart failure, uncontrolled high-risk arrhythmias Unstable angina, myocardial infarction, severe heart valve disease, and refractory hypertension; 8. History of soft meningitis; 9. Major cardiovascular disease (such as New York Heart Association Grade II) within 3 months prior to starting treatment research (or more severe heart disease, myocardial infarction or cerebrovascular accident), unstable arrhythmia or unstable angina pectoris Pain; 10. Received major surgical treatment (excluding diagnosis) within 4 weeks prior to the start of the study or is expected to be included in the study Perform major surgical treatment during this period; 11. Diagnosed as other malignant tumors within 5 years prior to initial administration, with exceptions including curative skin lesions Basal cell carcinoma, skin squamous cell carcinoma, fully treated in situ cervical cancer, localized prostate cancer; 12. Active infections that require systemic treatment; 13. Known to have fibrous layer HCC, sarcomatous HCC, or mixed cholangiocarcinoma and HCC; 14. Moderate or severe ascites; 15.History of hepatic encephalopathy; 16. Simultaneously infected with HBV and HCV; (1) Patients with a history of HCV infection but negative PCR results for HCV RNA can be considered not infected with HCV. 17. Diagnosed with immunodeficiency or receiving systemic glucocorticoid treatment within 7 days prior to the first administration of the study, or any other form of immunosuppressive therapy; (1)Physiological doses of glucocorticoids (<= 10mg/day of prednisone or equivalent) are allowed.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| objective response rate;overall survival;time to progression;duration of response;safety; | — |
Countries
China
Contacts
Public ContactZou Yanmei
Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
Outcome results
None listed