HCC - Hepatocellular Carcinoma
Conditions
Brief summary
This trial is designed to explore the efficacy and safety of interventional therapy combined with immune checkpoint inhibitors(ICIs) and anti-vascular endothelial growth factor(VEGF) antibody/tyrosine kinase inhibitors in the treatment of advanced hepatocellular carcinoma. Eligible participants will be divided into two groups based on their treatment plans: one receiving ICIs combined with anti-VEGF drugs, and the other receiving ICIs combined with anti-VEGF drugs alongside interventional therapy, which includes C-TACE, D-TACE, and HAIC. The specific number and interval of interventional therapy sessions will be determined according to the patient's individual condition. Researchers will closely monitor and rigorously evaluate the efficacy and safety of the treatment in participants through follow-up assessments. The primary endpoint is the objective response rate , while secondary endpoints include disease control rate, progression-free survival, overall survival, duration of response, adverse events, and serious adverse events.
Interventions
DRUGLenvatinib
≥60 kg: 12 mg once daily, or \<60 kg: 8 mg once daily
DRUGPembrolizumab
200 mg intravenously every three weeks
DRUGAtezolizumab
1200 mg intravenously every three weeks
DRUGBevacizumab
15mg/kg intravenously every three weeks
DRUGCamrelizumab
200 mg intravenously every three weeks
DRUGApatinib
250mg once daily
PROCEDURETACE
The specific number and interval of interventional therapy sessions will be determined according to the patient's individual condition.
PROCEDUREHAIC
The specific number and interval of interventional therapy sessions will be determined according to the patient's individual condition.
PROCEDUREDEB-TACE
The specific number and interval of interventional therapy sessions will be determined according to the patient's individual condition.
DRUGTislelizumab
200 mg intravenously every three weeks
DRUGSintilimab
200 mg intravenously every three weeks
Sponsors
Peking Union Medical College Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subjects voluntarily participate in the study, provide written informed consent, demonstrate good compliance, and are cooperative with follow-up. 2. Age ≥18 years at the time of signing informed consent, regardless of gender. 3. Diagnosis of hepatocellular carcinoma confirmed by imaging (according to AASLD criteria), histology, or cytology. 4. BCLC Stage B or C. 5. At least one measurable lesion per RECIST 1.1. 6. ECOG score of 0-1. 7. Child-Pugh liver function class A or B. 8. Life expectancy ≥ 3 months. 9. Adequate hematological and organ function.
Exclusion criteria
1. Patients with hepatocellular carcinoma who are candidates for surgical radical cure, or have undergone radical surgery without evaluable lesions, or have a history of or are planned for liver transplantation. 2. Pregnant or breastfeeding women. 3. Individuals with known allergy or intolerance to recombinant humanized PD-1/PD-L1 monoclonal antibody preparations. 4. Received local-regional therapy within 4 weeks before the first dose of the study drug, including but not limited to surgery, radiotherapy, hepatic artery embolism, TACE, hepatic artery infusion, radiofrequency ablation, cryoablation, or percutaneous ethanol injection. 5. History of other malignant tumors within 5 years prior to screening, except for hepatocellular carcinoma. 6. Presence of unhealed severe wounds, active ulcers, or untreated fractures. 7. Active autoimmune disease or history of autoimmune disorders. 8. Significant history of gastrointestinal diseases. 9. Significant history of cardiovascular or cerebrovascular diseases.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR, objective response rate | 12 months after the last subject is enrolled |
Secondary
| Measure | Time frame |
|---|---|
| OS, overall survival | 12 months after the last subject is enrolled |
| DCR, disease control rate | 12 months after the last subject is enrolled |
| PFS, progression free survival | 12 months after the last subject is enrolled |
| Adverse events (AE) | 12 months after the last subject is enrolled |
| Serious adverse events (SAE) | 12 months after the last subject is enrolled |
| DoR, duration of response | 12 months after the last subject is enrolled |
Countries
China
Contacts
Primary ContactShi Feng
Outcome results
None listed