Hepatocellular Carcinoma
Conditions
Brief summary
Systemic therapy is the primary option for managing advanced hepatocellular carcinoma (HCC). The combination of atezolizumab and bevacizumab (A+B) has emerged as the first-choice treatment for advanced HCC(IM brave 150). The ORIENT-32 study, also reported an ORR of 24% for sintilimab plus a bevacizumab biosimilar (S+B) versus 8% for sorafenib, with significantly longer OS and PFS. Based on those therapeutic advantages over sorafenib, both the A+B and S+B regimens were approved as first-line treatment options for advanced HCC in China. These two trials had very similar designs but included different target populations. Our previous studies have demonstrated that a novel treatment approach combining transarterial chemoembolization (TACE) with hepatic arterial infusion chemotherapy (HAIC) has high efficacy in patients with potentially resectable HCC or portal vein tumor thrombus. However, it remains unknown whether combining immune checkpoint inhibitors and macromolecular VEGF-targeted therapy with transvascular local interventions could improve patient prognosis in uHCC.
Interventions
Atezolizumab 1200 mg IV d1, Q3W, combined with bevacizumab 15 mg/kg IV d1, Q3W treatment, treatment continued until disease progression, development of intolerable toxic reactions
Sintilimab 200 mg IV d1, Q3W, combined with bevacizumab 15 mg/kg IV d1, Q3W treatment, treatment continued until disease progression, development of intolerable toxic reactions
PROCEDURETranscatheter arterial chemoembolization and hepatic arterial infusion chemotherapy
The chemoembolization process employed 30 mg/m2 of epirubicin and 2-10 mL of lipiodol. This was followed by FOLFOX-based HAIC, including 85 mg/m2 of oxaliplatin, 400 mg/m2 of leucovorin, and an initial bolus of 400 mg/m2 of 5-FU for 2 h, which was then followed by a sustained infusion of 1200 mg/m2 5-FU for 23 h.
Sponsors
Sun Yat-sen University
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* (a) a confirmed diagnosis of uHCC; * (b) at least one target lesion evaluable by both RECIST 1.1 and mRECIST criteria; * (c) Child-Pugh Grade A or B.
Exclusion criteria
* (a) previous exposure to other anti-cancer treatments; * (b) diagnosis of any other primary malignancy; * (c) significant esophageal varices or observable red wale marks; * (d) a history of severe cardiac, pulmonary, or renal comorbidities; * (e) incomplete follow-up records.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| objective response rate，ORR | 24 months | Evaluated according to the criteria for evaluating efficacy in solid tumors (mRECIST and RECIST 1.1) |
| progression free survival，PFS | 24 months | Assessed using the mRECIST criteria, defined as patient survival without tumor progression from the start of randomization to the end of year 2 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| treatment-related adverse events, TRAEs | 24 months | incidence rates of treatment-related adverse events during the study |
| overall survival, OS | 24 months | Defined as the time from the start of randomization to death from any cause |
Countries
China
Outcome results
None listed