Hepatocellular Carcinoma (HCC)
Conditions
Keywords
transarterial chemoembolization, hepatocellular carcinoma, immune checkpoint inhibitors, molecular target therapies
Brief summary
Immune checkpoint inhibitors and anti-vascular endothelial growth factor antibody/tyrosine kinase inhibitors with or without transarterial chemoembolization as first-line treatment for advanced hepatocellular carcinoma with vascular invasions
Detailed description
The vascular invasions is a common complication in 16% to 30% of patients with hepatocellular carcinoma (HCC), contributing to poor prognosis and increasing the risk of cancer recurrence, with a median survival of approximately 2.7 to 4 months without intervention. Both the European Association for the Study of the Liver and the American Association for the Study of Liver Diseases guidelines recommend that HCC patients with vascular invasions be classified as Barcelona Clinic Liver Cancer Stage C and receive systemic treatments. Nevertheless, there is limited data on patients with highly complicated HCC and no optimal treatment strategy for this patient population. anti-vascular endothelial growth factor antibody/tyrosine kinase inhibitors and immune checkpoint inhibitors (ICIs) are commonly utilized in the systemic therapy of HCC, while the combination of transcatheter arterial chemoembolization (TACE) with systemic therapy has significantly improved treatment outcomes in advanced-stage patients. Therefore, we hypothesized that a triplet regimen comprising TACE,anti-vascular endothelial growth factor antibody/tyrosine kinase inhibitors, and ICIs may yield better prognoses for HCC patients with vascular invasions. This study aims to compare the safety and efficacy of the triplet regimen of anti-vascular endothelial growth factor antibody/tyrosine kinase inhibitors, ICIs, and TACE versus Lenvatinib combined with ICIs in advanced-stage HCC with vascular invasions
Interventions
None listed
Sponsors
Zhongda Hospital
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Inclusion criteria
1. Has a diagnosis of HCC confirmed by radiology, histology, or cytology; 2. Barcelona Clinic Liver Cancer (BCLC) stage C with the presence of macrovascular invasion; 3. Has not received any previous systemic therapy for HCC (including chemotherapy, molecularly targeted therapy, immunotherapy); 4. Both PD-1/PD-L1 inhibitors and anti-angiogenesis drugs patients received only include marketed drugs but are not limited to HCC approval; 5. TACE was performed after the first PD-1/PD-L1 inhibitor/anti-angiogenic drug treatment or before treatment (within 3 months); 6. Received at least 1 cycle of PD-1/PD-L1 inhibitor/anti-angiogenic drug combination therapy after TACE treatment; 7. Has repeated measurable intrahepatic lesions;
Exclusion criteria
1. Cholangiocarcinoma, fibrolamellar, sarcomatoid hepatocellular carcinoma, and mixed hepatocellular/cholangiocarcinoma subtypes(confirmed by histology, or pathology) are not eligible; 2. Unable to meet criteria of combination timeframe described above; 3. Child-Pugh C or PS\>2 or Severe hepatic encephalopathy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival(OS) | up to approximately 2 years | The OS is defined as the time from the initiation of any combination treatment to death due to any cause. |
| Progression free survival(PFS) according to per mRECIST or RECIST 1.1 | up to approximately 2 years | per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Description: The PFS is defined as the time from the initiation of any combination treatment to the first documented progressive disease (according to RECIST 1.1) or death due to any cause, whichever occurs first. PFS per Modified Response Evaluation Criteria in Solid Tumors (mRECIST) Description: The PFS is defined as the time from the initiation of any combination treatment to the first documented progressive disease (according to mRECIST) or death due to any cause, whichever occurs first. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ORR per mRECIST | up to approximately 2 years | The ORR is defined as the proportion of patients with a documented CR or PR per mRECIST |
| Objective response rate(ORR) per RESCIST 1.1 | up to approximately 2 years | The ORR is defined as the proportion of patients with a documented complete response(CR) or partial response(PR) per RECIST 1.1. |
| Adverse event(AE) per Common Terminology Criteria for Adverse Events(CTCAE) 5.0 | up to approximately 2 years | The percentage and degree of patients who experience at least one AE, whether or not considered related to the treatment, according to CTCAE version 5.0. |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORGao-Jun Teng, M.D
Zhongda hospital, Southeast university, Nanjing, China
Outcome results
None listed