Hepatocellular Carcinoma
Conditions
Keywords
hepatocellular carcinoma, transarterial chemoembolization, immune checkpoint inhibitors, molecular target therapies, Intermediate stage
Brief summary
The purpose of this study is to evaluate the safety and efficacy of transarterial chemoembolization (TACE) in combination with PD-1/PD-L1 Inhibitors and molecular target therapies in patients with Intermediate-stage hepatocellular carcinoma (HCC).
Detailed description
Transarterial chemoembolization (TACE) can induce immunogenic cell death and tumor-specific immune response which results in the release of tumor antigens and transform "cold" tumors with lacking immune effector cells into "hot" tumors with immune effector cells infiltration. This provides a theoretical basis for TACE combined with immune checkpoint inhibitors (ICIs) in hepatocellular carcinoma (HCC) patients. The purpose of this study is to evaluate the safety and efficacy of transarterial chemoembolization (TACE) in combination with PD-1/PD-L1 Inhibitors and molecular target therapies(including, VEGF-TKI/ bevacizumab) in patients with Intermediate-stage HCC. This real-world study also would like to explore the optimal combined treatment and subgroup of HCC patients for providing further information for clinical practice and trials.
Interventions
PD-1/PD-L1 inhibitors: atezolizumab, sintilimab, pembrolizumab, nivolumab, camrelizumab, tislelizumab, toripalimab, durvalumab, penpulimab, and other ICIs; VEGF-TKI/bevacizumab: sorafenib, lenvatinib, donafenib, apatinib, anlotinib, bevacizumab/ bevacizumab biosimilar, and other anti-angiogenesis drugs; Both PD-1/PD-L1 inhibitors and anti-angiogenesis drugs only include marketed drugs but are not limited to HCC approval.
PROCEDURETACE
TACE: cTACE (conventional TACE) or dTACE (drug-eluting beads TACE);
Sponsors
Zhongda Hospital
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Has a diagnosis of HCC confirmed by radiology, histology, or cytology; 2. Barcelona Clinic Liver Cancer (BCLC) stage B, without the presence of extrahepatic spread and/or macrovascular invasion; 3. Has not received any previous TACE/HAIC and 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; 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 according to mRECIST;
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression free survival(PFS) per Modified Response Evaluation Criteria in Solid Tumors (mRECIST) | 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. |
| 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 |
|---|---|---|
| PFS per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) | 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 RECIST 1.1) or death due to any cause, whichever occurs first. |
| Objective response rate(ORR) per mRECIST | 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 mRECIST. |
| Duration of Response (DOR) per mRECIST | up to approximately 2 years | DOR is determined by disease assessment and is defined as the time from the first documented evidence of a response of CR or PR until the first documented disease progression (according to mRECIST) or death due to any cause, whichever occurs first. |
| Disease Control Rate (DCR) per mRECIST | up to approximately 2 years | DCR is defined as the percentage of participants who have a best overall response of CR, PR, or stable disease (SD) per mRECIST. |
| 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. |
| DOR per RESCIST 1.1 | up to approximately 2 years | DOR is determined by disease assessment and is defined as the time from the first documented evidence of a response of CR or PR until the first documented disease progression (according to RESCIST 1.1) or death due to any cause, whichever occurs first. |
| DCR per RESCIST 1.1 | up to approximately 2 years | DCR is defined as the percentage of participants who have a best overall response of CR, PR, or stable disease (SD)per RESCIST 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
PRINCIPAL_INVESTIGATORZheng-Gang Ren, M.D.
Liver Cancer Institute, Zhongshan Hospital, Fudan University, Shanghai, China
Outcome results
None listed