Hepatocellular Carcinoma (HCC)
Conditions
Brief summary
The safety, clinical efficacy and prognostic factors of transcatheter arterial chemoembolization (TACE) and/or hepatic artery infusion chemotherapy (HAIC) combined with targeted immunotherapy for primary hepatocellular carcinoma (HCC) require further in-depth study. This research aims to evaluate the safety, clinical efficacy and prognostic factors of TACE and/or HAIC combined with targeted immunotherapy for hepatocellular carcinoma. We are going to compare and analyze local tumor response, survival outcomes, prognostic factors and adverse events. Tumor response was evaluated according to the modified Response Evaluation Criteria in Solid Tumors (mRECIST) version. Adverse events were evaluated using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. This study intends to include the targeted and immunotherapy applied, mainly including: lenvatinib, sorafenib, apatinib, bevacizumab, etc.; pembrolizumab, carfilzomib, sintilimab and teprotumumab, etc.
Interventions
transarterial chemoembolization
Sponsors
Study design
Eligibility
Inclusion criteria
* aged 18-80 years * Eastern Cooperative Oncology Group (ECOG) performance status score \< 2 * maximum tumor diameter ≥ 7 cm * IVC/RA TT diagnosed by contrast-enhanced CT / MRI before study treatment * unresectable HCC (uHCC) confirmed by a specialized multidisciplinary team * liver function of Child-Pugh class A or B
Exclusion criteria
* with other malignancies * prior anti-tumor therapy * history of drug allergy * autoimmune diseases * digestive hemorrhage of any grade * insufficient renal, bone marrow, or coagulation function
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival(OS) | 1-, 2-, 3-, and 5-year | OS was calculated as the duration from the date of the first cycle of the study combination therapy to the date of death or last date of follow-up. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival (PFS) | 1-, 2-, and 3-year | PFS was defined as the duration from the date of the first cycle of the combination therapy to tumor lesion progression, death, or last follow-up, whichever came first. |
Countries
China