A Randomized Phase 2 Study to Evaluate the Safety and Efficacy of IP-001 as Adjuvant Therapy in Participants With Hepatocellular Carcinoma After Complete Radiological Response After Surgical Resection and Local Ablation or Local Ablation Alone
Robert C. Martin
Summary
The purpose of this study is to evaluate the safety and efficacy of a single injection of IP-001 as adjuvant therapy after local ablation or surgical resection and ablation in patients with hepatocellular carcinoma (HCC).
Description
This is a Phase 2, two-armed, randomized study designed to evaluate the safety and efficacy of a single administration of intratumoral IP-001 injection 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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 either a curative ablation (RFA or MWA) or a curative surgical resection and ablation. * Has HCC with intermediate, high or very high risk of recurrence. * Has hepatic only HCC (disease confined to the liver only), defined by no extra-hepatic lesions greater than 1 cm in size. * Has an Easte…
Interventions
- Drug1.0% IP-001 for injection
Participants will receive a single injection of 1.0% IP-001 following local ablation or surgical resection and local ablation
- ProcedureSurgical Resection and Local Ablation
Participants will undergo surgical resection of the tumor and local ablation by either radiofrequency ablation (RFA ) or microwave ablation (MWA)
- ProcedureLocal Ablation Alone
Participants will have local ablation of the tumor by either radiofrequency ablation (RFA) or microwave ablation (MWA) alone
Location
- University of LouisvilleLouisville, Kentucky