hepatocellular carcinoma
Conditions
Interventions
Regorafenib Plus Tislelizumab Group:Regorafenib Combined with Tislelizumab Therapy
Regorafenib Group:Regorafenib Monotherapy
Sponsors
Beijing Ditan Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Patients with hepatocellular carcinoma (HCC) receiving second-line treatment; 2. Age between 18 and 80 years; 3. Histologically confirmed or clinically diagnosed HCC according to the 2022 Guidelines for the Diagnosis and Treatment of Primary Liver Cancer in China; 4. Patients with unresectable disease, ineligible for liver transplantation or local curative treatments (e.g., ablation), or those who have relapsed after curative treatment; 5. Child-Pugh class A or B liver function (score = 3.0 × 10?/L, Platelets >= 70 × 10?/L, Hemoglobin >= 80 g/L, ALT = 28 g/L, Creatinine clearance (CCr) >= 80 mL/min; 8. For patients with HBV infection: HBV DNA 1 cm on contrast-enhanced CT or MRI); 11. Willingness to provide written informed consent; 12. Estimated overall survival >= 3 months.
Exclusion criteria
Exclusion criteria: 1. Receipt of local radiotherapy or radiofrequency ablation within the past month (except for non-progressive lesions treated locally only); 2. Symptomatic brain metastases; 3. Active bleeding tendency; 4. Uncontrolled hypertension; 5. Concurrent malignancies that have not been cured (excluding carcinoma in situ); 6. Active infections; 7. History of heart failure, unstable angina, or myocardial infarction within the past year; 8. Active autoimmune diseases (e.g., Sjögren’s syndrome, systemic lupus erythematosus, etc.); 9. Severe psychiatric disorders that interfere with treatment compliance or the ability to provide informed consent; 10. Patients on warfarin anticoagulation therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival;Objective Response Rate; | — |
Countries
CHina
Contacts
Public ContactXiaoyan Ding
Beijing Ditan Hospital, Capital Medical University
Outcome results
None listed