Phase III Study of Autologous Dendritic Cell Vaccine with Prevnar and Immune Checkpoint Inhibitors After High-Dose Radiation in Patients with Unresectable Liver Cancer

What this Trial Is About

Researchers are evaluating the safety and effects of combining autologous dendritic cells and a pneumonia vaccine called Prevnar with immune checkpoint inhibitors bevacizumab and atezolizumab or durvalumab after high-dose external beam radiotherapy in patients with unresectable liver cancer. This early phase I trial focuses on liver cancers that cannot be removed by surgery, including hepatocellular carcinoma and intrahepatic cholangiocarcinoma, aiming to stimulate the immune system to attack tumors. Participants undergo apheresis to produce dendritic cells from their own white blood cells, followed by high-dose external beam radiotherapy over 1 to 3 weeks. After radiation, patients receive intratumoral injections of the dendritic cells and intramuscular injections of the Prevnar vaccine, combined with intravenous immune checkpoint inhibitors atezolizumab and bevacizumab or durvalumab depending on the group assignment. Treatment cycles repeat every 21 or 28 days for up to 7 cycles, depending on the group, unless disease progression or unacceptable toxicity occurs. Throughout the study, participants have various assessments including imaging scans CT, PETCT, MRI, biopsies, blood and urine sample collections, and esophagogastroduodenoscopy at screening. After completing treatment, they are followed up at 2 weeks and then every 3 months for one year, continuing follow-up every 3 months until disease progression and then every 6 months up to 5 years. Researchers measure safety, progression-free survival, overall response, clinical benefit, time and duration of response, and overall survival among other outcomes.

Modified Immune Cells (Autologous Dendritic Cells) and a Vaccine (Prevnar) Combined With Immune Checkpoint Inhibition After High-Dose External Beam Radiation Therapy in Treating Patients With Unresectable Liver Cancer