Hepatocellular carcinoma
Conditions
Interventions
Regorafenib with immune checkpoint inhibitors group:Regorafenib was initially administered orally once daily at a dosage of 80-160 mg depending on patient’s tolerance, for the first 3 weeks of each 4-
Regorafenib monotherapy group:Regorafenib was initially administered orally once daily at a dosage of 80-160 mg depending on patient’s tolerance, for the first 3 weeks of each 4-week cycle.
Sponsors
Sun Yat-sen University Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age between 18 and 75 years; 2. Patients diagnosed with HCC according to the diagnostic criteria of the Chinese guidelines for the diagnosis and treatment of primary liver cancer or confirmed by histopathological examination; 3. Presence of at least one lesion measurable by computer tomography or magnetic resonance imaging according to mRECIST and RECIST1.1 criteria; 4. Barcelona Clinic Liver Cancer (BCLC) stage B or C; 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1; 6. Child-Pugh class A or B liver function; 7. Received either regorafenib monotherapy or the combination of regorafenib with PD-1/PD-L1 inhibitors as second-line systemic treatment after progression on first-line therapy.
Exclusion criteria
Exclusion criteria: 1. Concomitant malignancies; 2. Progressive or symptomatic central nervous system metastases; 3. History of human immunodeficiency virus infection or acquired immunodeficiency syndrome; 4. Active pulmonary tuberculosis or other active infections; 5. Active autoimmune diseases or history of potentially recurrent autoimmune diseases; 6. History of mental disorders or cognitive dysfunction; 7. Allergy to any of the investigational drug or its components; 8. Decompensated liver function, including massive ascites, gastrointestinal bleeding, or hepatic encephalopathy; 9. Renal insufficiency requiring peritoneal dialysis or hemodialysis; 10. Severe dysfunction of other important organs; 11. Inability to assess efficacy or incomplete essential medical information; 12. Lost to follow-up or follow-up duration of less than 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival (OS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS);Complete response (CR);Partial response (PR);Stable disease (SD);Progressive disease (PD);Objective response rate (ORR);Disease control rate (DCR); | — |
Countries
China
Contacts
Public ContactLi Binkui
Sun Yat-sen University Cancer Center
Outcome results
None listed