BCLC Stage B Hepatocellular Carcinoma, BCLC Stage C Hepatocellular Carcinoma, Hepatic Arterial Infusion Chemotherapy, Lenvatinib, PD-1, Systemic Therapy
Conditions
Brief summary
The purpose of this study is to evaluate the safety and efficacy of hepatic arterial infusion chemotherapy (HAIC) in combination with PD-1 inhibitors and Lenvatinib in patients with intermediate or advanced-stage hepatocellular carcinoma (HCC) after failure of systemic therapy recommended by BCLC.
Interventions
PROCEDUREhepatic artery infusion chemotherapy
Hepatic arterial infusion chemotherapy including FOLFOX and RALOX
PD-1 inhibitors including Camrelizumab, Sintilimab, Tislelizumab
Sponsors
First Hospital of China Medical University
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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 portal vein tumor thrombus; 3. Has received previous systemic therapy recommended for HCC by BCLC, and the systemic therapy failed; 4. Both PD-1inhibitors and Lenvatinib patients received only include marketed drugs but are not limited to HCC approval; 5. HAIC was performed after the first PD-1 inhibitor/ Lenvatinib treatment or before treatment; 6. Received at least 2 cycles of HAIC； 7. Has repeated measurable intrahepatic lesions; 8. Child-Pugh class A or B.
Exclusion criteria
1. The interval between the failure of systemic therapy and the beginning of combination therapy longer than 3 months; 2. With other malignant tumors; 3. Unable to meet criteria of combination timeframe described above.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression free survival(PFS) of intra-hepatic lesions | Up to approximately 2 years | The PFS is defined as the time from the initiation of any combination treatment to the first documented progressive disease of intra-hepatic lesions or death due to any cause, whichever occurs first. |
| Progression free survival(PFS) of extra-hepatic lesions | Up to approximately 2 years | The PFS is defined as the time from the initiation of any combination treatment to the first documented appearance of extra-hepatic lesions or death due to any cause, whichever occurs first. |
| Progression free survival(PFS) of portal vein tumor thrombus (PVTT) | Up to approximately 2 years | The PFS is defined as the time from the initiation of any combination treatment to the first documented progressive disease of PVTT or death due to any cause, whichever occurs first. |
| Progression free survival(PFS) (Overall) | Up to approximately 2 years | 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. |
| 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. |
| ORR of PVTT | Up to approximately 2 years | The ORR is defined as the proportion of patients with a documented CR or PR of PVTT. |
| 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. |
| 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. |
Countries
China
Contacts
Primary ContactJiaxi Liu
Outcome results
None listed