hepatocellular carcinoma, HCC
Conditions
Interventions
Experimental group:Regorafenib Combined with Pembrolizumab
Sponsors
The Third Affiliated Hospital of Sun Yat-Sen University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Pathologically and/or clinically diagnosed with Hepatocellular Carcinoma (HCC); 2. Patients with CNLC stage IIB or above who cannot benefit from higher-priority established effective treatments, such as resection or local ablation; 3. Child-Pugh class A/B; 4. Expected lifespan > 3 months; 5. At least one measurable lesion according to RECIST v1.1; 6. ECOG PS score of 0-1; 7. Objective radiographic progression during or after first-line treatment or intolerance to first-line treatment; 8. Aged 18 years and above; 9. Female and male participants of reproductive potential must agree to use adequate contraception from the start of the first dose of study drug, throughout the study, and for up to 120 days after the last dose of study drug, and males cannot participate in sperm donation during this period; 10. Voluntary participation in the study and signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating patients, and those planning pregnancy during the study period and within six months after the end of the study; 2. Patients unable to take oral medications; 3. Patients with mental illness or substance abuse; 4. Patients currently participating in or previously participated in other clinical trials; 5. Patients with immunodeficiency such as HIV infection; 6. Patients receiving other medications that may affect immune system function; 7. Patients with autoimmune diseases or who have received immunosuppressive therapy in the past six months; 8. Patients who have undergone solid organ or hematopoietic transplantation; 9. Vaccination with inactivated vaccines within 30 days before the first dose of the study treatment; 10. Patients with active infections requiring systemic treatment; 11. Uncontrolled hypertension (systolic blood Patients with severe renal impairment; pressure [BP] > 150 mmHg or diastolic blood pressure > 90 mmHg despite optimal drug therapy); 12. Uncontrolled ascites (defined as difficult-to-control with diuretics or paracentesis); 13. Interstitial lung disease with persistent signs and symptoms at screening; 14. History of (non-infectious) pneumonia requiring steroid therapy or currently active pneumonia; 15. History of esophageal or gastric variceal bleeding within the past 6 months; 16. Arterial or venous thrombosis or embolism events within 6 months before enrollment, such as cerebrovascular accidents (including transient ischemic attacks), deep vein thrombosis, or pulmonary embolism; 17. Clinical diagnosis of hepatic encephalopathy within the past 6 months; 18. Patients with significant bleeding risk; 19. Patients with known progressive or actively treated other malignancies; 20. Patients experiencing adverse reactions to other medications and not yet recovered; 21. Other factors that may confound the results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-Free-Survival;Time-To-Progression;Disease Control Rate;Overall survival;Response Evaluation Criteria in Solid Tumours v1.1;Common Terminology Criteria for Adverse Events 5.0;European Organization for Research and Treatment of Cancer Quality of Life Questionnaire; | — |
Countries
China
Contacts
Public ContactMeihai Deng
The Third Affiliated Hospital of Sun Yat-Sen University
Outcome results
None listed