Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Tislelizumab · 1 trial · 2 indications
Number of participants experiencing adverse events grade three or higher, as defined by Common Terminology Criteria for Adverse Events version 5.0 (NCI-CTCAE v5.0). Severity is a measure of intensity (eg, grade of a specific AE, mild \[Grade 1\], moderate \[Grade 2\], severe \[Grade 3\], or life-threatening \[Grade 4\]), whereas seriousness is classified by the criteria based on the regulatory definitions. Seriousness serves as the guide for defining regulatory reporting obligations from the Investigator Sponsor to applicable regulatory authorities as described in CTCAE version 5.0.
| Arm | Type | Description |
|---|---|---|
| Tislelizumab in conjunction with radiation therapy | EXPERIMENTAL | Participants will receive local therapy including TACE+ RT or Ablation (tumors with incomplete ablation) + RT or RT alone (for patients not eligible for TACE or Ablation) and will be screened for eligibility prior to enrollment. Once eligibility has been confirmed, Tislelizumab will be started before radiation therapy and will continue after radiation therapy. Participants who do not receive Tislelizumab for a total of two cycles will be replaced and interpreted for only toxicity analysis. |
| Name | Type | Description |
|---|---|---|
| Tislelizumab | DRUG | Tislelizumab (also known as BGB A317) is a humanized, immunoglobulin G4 (IgG4)-variant monoclonal antibody against programmed cell death protein-1 (PD-1) under clinical development for the treatment of several human malignancies. Tislelizumab consolidation therapy after radiation therapy can capitalize on the immunomodulatory effect of radiotherapy and improve tumor responses and patient outcomes. |
Inclusion Criteria: * Each patient eligible to participate in this study must meet all the following criteria: 1. Written informed consent 2. Primary diagnosis of HCC, planned to receive radiation, treatment naïve to systemic therapy for HCC, prior TACE permitted 3. Hepatocellular carcinoma ...
Tislelizumab is an investigational antibody being studied as consolidation therapy after liver-directed treatment for hepatocellular carcinoma, a type of liver cancer. It is currently in a Phase 2 clinical trial in the United States for this indication.
Tislelizumab is a monoclonal antibody, indicated by its -mab suffix. It is being evaluated in hepatocellular carcinoma, where it is given after liver-directed therapy. The specific molecular target is not disclosed in the available clinical trial information.
Tislelizumab is being developed by Natera, Inc., a company traded on NASDAQ under the ticker NTRA. The company is conducting a Phase 2 trial of the drug in patients with hepatocellular carcinoma.
Tislelizumab is in Phase 2 clinical development. It is an investigational drug, not yet approved by regulatory authorities. The ongoing Phase 2 trial is recruiting patients with hepatocellular carcinoma in the United States.
Tislelizumab is being studied in a single Phase 2 clinical trial with the identifier NCT05366829. The trial, titled 'Tislelizumab Consolidation After Liver-Directed Therapy for Hepatocellular Carcinoma,' is recruiting 35 participants aged 18 years and older in the United States.
Tislelizumab is a distinct drug candidate with no alternative names listed in the available clinical trial information. It is being investigated under its own name in the Phase 2 trial for hepatocellular carcinoma.