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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
126
Participants will receive a single injection of 1.0% IP-001 following local ablation or surgical resection and local ablation
Participants will undergo surgical resection of the tumor and local ablation by either radiofrequency ablation (RFA ) or microwave ablation (MWA)
Participants will have local ablation of the tumor by either radiofrequency ablation (RFA) or microwave ablation (MWA) alone
University of Louisville
Louisville, Kentucky, United States
RECRUITINGRecurrence Free Survival
Radiological assessments (Triphasic CT or MRI) of the chest, abdomen and pelvis will occur every 12 weeks for the first 2 years, then every 24 weeks thereafter. Recurrence will be determined by the investigator's radiological review per RECIST v1.1
Time frame: From Date of Randomization until date of documented progression, assessed up to 60 months
Cancer Free Survival
Participants will be followed every 12 weeks from treatment Day 1 for the first 2 years, and every 24 weeks thereafter until disease related death.
Time frame: Months 12 and 24
Overall Survival
Participants will be followed every 12 weeks from treatment Day 1 for the first 2 years, and every 24 weeks thereafter until death of any cause.
Time frame: Months 12 and 24
Overall Survival Rate
Proportion of participants who have not experienced death from treatment Day 1 at 12 and 24 months after treatment.
Time frame: Months 12 and 24
Recurrence Free Survival Rate
Assessed from treatment Day 1 to documentation of disease recurrence or extrahepatic) or death, whichever occurs first.
Time frame: Months 12 and 24
Time to Intrahepatic Tumor Recurrence
Radiological assessments (Triphasic CT or MRI) of the chest, abdomen and pelvis will occur every 12 weeks for the first 2 years, then every 24 weeks thereafter. Recurrence will be determined by the investigator's radiological review per RECIST v1.1
Time frame: From Date of Randomization until date of documented progression, assessed up to 60 months
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Time to Extrahepatic Tumor Recurrence
Radiological assessments (Triphasic CT or MRI) of the chest, abdomen and pelvis will occur every 12 weeks for the first 2 years, then every 24 weeks thereafter. Recurrence will be determined by the investigator's radiological review per RECIST v1.1
Time frame: From Date of Randomization until date of documented progression, assessed up to 60 months