Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Immune Checkpoint Inhibitor · 1 trial · 1 indication
Number of patients amendable to curative surgical interventions defined as number of patients receiving curative surgical resection or transplantation after successful down-sizing of tumor(s) by intervention.
| Arm | Type | Description |
|---|---|---|
| START-FIT | EXPERIMENTAL | Single group assignment combining TACE and SBRT with immune checkpoint inhibitor as treatment in HCC patients. Procedure of TACE will be standardized. SBRT screening and planning will be performed by radiation therapists, medical physicists, and oncologists. An immune checkpoint inhibitor may be administered up to 3 days before or after the scheduled day of administration of each cycle due to administrative reasons. |
| Name | Type | Description |
|---|---|---|
| TACE | PROCEDURE | Procedure of TACE will be standardized. |
| SBRT | RADIATION | SBRT screening and planning will be performed by radiation therapists, medical physicists, and oncologists. |
| Immune Checkpoint Inhibitor | DRUG | An immune checkpoint inhibitor may be administered up to 3 days before or after the scheduled day of administration of each cycle due to administrative reasons. |
Inclusion Criteria: 1. Diagnosis of HCC confirmed pathologically or made according to American Association for the Study of Liver Diseases (AASLD) practice guideline 2010: patients with cirrhosis of any etiology and patients with chronic hepatitis B (HBV) who may not have fully developed cirrhosis,...
Immune Checkpoint Inhibitor is an investigational small molecule being studied for the treatment of hepatocellular carcinoma (HCC). It is being evaluated in a Phase 2 clinical trial as part of a sequential treatment approach involving TACE and SBRT followed by immunotherapy, with the goal of downstaging HCC for hepatectomy.
Immune Checkpoint Inhibitor is being developed by Merck KGaA, a science and technology company. The company's stock is traded under the ticker MKGAF. The drug is currently in clinical development for hepatocellular carcinoma.
Immune Checkpoint Inhibitor is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 2 trial has been completed, and the drug is still being studied for the treatment of hepatocellular carcinoma.
Immune Checkpoint Inhibitor has been studied in one clinical trial, identified as NCT03817736. This Phase 2 trial, titled 'Sequential TACE and SBRT Followed by ImmunoTherapy for Downstaging HCC for Hepatectomy,' was conducted in Hong Kong and enrolled 33 participants with hepatocellular carcinoma. The trial has been completed.
Immune Checkpoint Inhibitor is a small molecule being studied in a biomarker-selected patient population. The clinical trial for this drug enrolled patients with hepatocellular carcinoma, and the study was designed to evaluate the drug's effect in this specific patient group.