HCC - Hepatocellular Carcinoma, Hepatic Arterial Infusion Chemotherapy, BCLC Stage C Hepatocellular Carcinoma, Lenvatinib, PD-1 Inhibitors
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 high tumor burden advanced-stage hepatocellular carcinoma (HCC) with portal vein tumor thrombus (PVTT).
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 80 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18 to 80 years old; 2. Diagnosis of HCC was confirmed by histologic or cytologic analysis or clinical features according to the American Association for the Study of Liver Diseases (AASLD) guideline; 3. At least one measurable intrahepatic lesion as per the RECIST 1.1 criteria; 4. HCC staging of the patients are consistent with both the BCLC stage C and the CNLC stage IIIa. 5. Presence of PVTT; 6. Patients received a first-line lenvatinib+PD-1 (L+P) inhibitors combination or that of HAIC+lenvatinib+PD-1 inhibitors (H+L+P). More specifically, the administration of lenvatinib was concomitant with PD-1 inhibitors, and HAIC was performed either concurrently with, or up to 2 months before or after the L+P inhibitors combination therapy. Patients in the H+L+P group should undergo at least 2 cycles of HAIC, receive at least 2 cycles of PD-1 inhibiors and take at least 2 months of lenvatinib. Patients in the L+P group should receive at least 2 cycles of PD-1 inhibiors, and take at least 2 months of lenvatinib. 7. Child-Pugh class A or B7; 8. Tumor burden meets up to 7 out criteria.
Exclusion criteria
1. Patients who took anti-tumor treatments before the combination therapy; 2. With other malignant tumors; 3. incomplete data.
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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORHaibo Shao
First Hospital of China Medical University
Outcome results
None listed