Table 7.
Ongoing Clinical Trials of ICIs in Patients With HBV Infection and Advanced-Stage Cancer
| Trial | NCT Trial No | Location | ICI | Tumor | Phase | Study Type | Sample size | Primary Endpoint |
|---|---|---|---|---|---|---|---|---|
| P1101 and Anti-PD1 for After Curative Surgery of Hepatitis B-related Hepatocellular Carcinoma | NCT04233840 | Taiwan | Nivolumab | HCC | I/II | Interventional (Clinical Trial) | 72 | Dose-limiting Toxicity/Recurrence-free survival |
| Pembrolizumab in Hepatocellular Carcinoma | NCT03419481 | Hongkong | pembrolizumab | HCC | II | Interventional (Clinical Trial) | 30 | Response rate |
| Atezolizumab Plus Bevacizumab for Patients With Advanced Hepatocellular Carcinoma (HCC) and Chronic Hepatitis B Virus (HBV) Infection | NCT04180072 | Taiwan | Atezolizumab | HCC | II | Interventional (Clinical Trial) | 48 | Best overall response rate Best overall response rate |
| Durvalumab for Advanced Hepatocellular Carcinoma in Patients With Active Chronic Hepatitis B Virus Infection | NCT04294498 | Taiwan | Durvalumab | HCC | II | Interventional (Clinical Trial) | 43 | The rate of HBV reactivation |
| Safety and Immunotherapeutic Activity of Cemiplimab in Participants With HBV on Suppressive Antiviral Therapy | NCT04046107 | Los Angeles | Cemiplimab | Nil | I/II | Interventional (Clinical Trial) | 30 | Targeted safety events/Number of discontinue treatment |
HCC=Hepatocellular Carcinoma; HBsAg=Hepatitis B surface antigen.