A Study of the Application of HAIC in Advanced HCC Previously Treated With ICIs and Antian
Immune checkpoint inhibitors (ICIs) plus antiangiogenic agents can achieve better efficacy than sorafenib in the treatment of hepatocellular carcinoma (HCC) within a certain period of time, but more than half of the patients are still insensitive to the treatment. There is no evidence-based basis for second-line treatm
| Condition(s) | Hepatocellular Carcinoma |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | Immune checkpoint inhibitors (ICIs) plus antiangiogenic agents can achieve better efficacy than sorafenib in the treatment of hepatocellular carcinoma (HCC) within a certain period of time, but more than half of the patients are still insensitive to the treatment. There is no evidence-based basis for second-line treatment after the progression of the disease.In view of the effectiveness of Hepatic arterial infusion (HAIC) in the first-line treatment of HCC in the Chinese population, this study intends to launch a prospective intervention study to explore the efficacy and safety of HAIC treatment in patients with advanced HCC after the failure of ICIs and antiangiogenic agents combination therapy, and to provide high-level evidence for optimizing the second-line treatment of advanced HCC in |
| Who can participate | Inclusion Criteria: Cytohistological confirmation is required for diagnosis of HCC. Patients with advanced (unresectable and/or metastatic, stage C based on Barcelona-Clinic Liver Cancer \[BCLC\] staging classification) hepatocellular carcinoma. At least one tumor lesion meeting measurable disease criteria as determined by RECIST v1.1. Current cirrhotic status of Child-Pugh class A-B, with no encephalopathy. Ascites controlled by diuretics is permitted in this study. Availability of a representative tumor tissue specimen (archival tumor tissue is allowed) at pre-screening. Eastern Cooperative Oncology Group Scale for Assessment of Patient Performance Status ≤ 2. Both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial and 4 w |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Lead sponsor | Sun Yat-sen University |
| Locations | Guangzhou, Guangdong, China |
| Start date | 2022-10-18 |
| NCT ID | NCT05718492 |
| Official listing | https://clinicaltrials.gov/study/NCT05718492 |