Robert C. Martin
The purpose of this study is to evaluate the safety and efficacy of administration of intratumoral IP-001 injection at different dosages (volume and concentration) following local microwave ablation (MWA) or surgical resection and ablation in patients with hepatocellular carcinoma (HCC).
This is a Phase 2, five-armed, randomized study designed to evaluate the safety and efficacy of administration of intratumoral IP-001 injection at different dosages (volume and concentration) following local ablation or surgical resection and local ablation in patients with hepatocellular carcinoma who have an intermediate or high risk of recurrence compared to curative ablation or ablation and surgical resection.
Inclusion Criteria: * Age ≥ 18 years at time of signing Informed Consent. * Has a diagnosis of hepatocellular carcinoma (HCC) documented radiologically by American Association for the Study of Liver Diseases (AASLD) criteria and/or histopathologically from a tumor biopsy. * Has a treatment plan to receive a curative ablation (MWA only) or a curative surgical resection and ablation, or where the patient may benefit from surgery and ablation or ablation prior to receiving anti-cancer therapy. * Has HCC with intermediate, high or very high risk of recurrence. * Has hepatic only HCC (disease conf…
Participants will receive intratumoral injection of 1.0% IP-001 following local microwave ablation or surgical resection and local microwave ablation
Participants will undergo surgical resection of the tumor and local microwave ablation
Participants will have local ablation of the tumor by microwave ablation alone
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