Adjuvant IP-001 Treatment for HCC Patients Following Surgical Resection and Ablation or Ablation Alone

Part of paid clinical trials in Louisville, Kentucky.

Sponsor
Robert C. Martin
Study ID
NCT06526338
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 1.0% IP-001 for injection — DRUG
    Participants will receive a single injection of 1.0% IP-001 following local ablation or surgical resection and local ablation
  • Surgical Resection and Local Ablation — PROCEDURE
    Participants will undergo surgical resection of the tumor and local ablation by either radiofrequency ablation (RFA ) or microwave ablation (MWA)
  • Local Ablation Alone — PROCEDURE
    Participants will have local ablation of the tumor by either radiofrequency ablation (RFA) or microwave ablation (MWA) alone

Study Details

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).

Key Dates

Start date
Jul 24, 2024
Status verified
Sep 2025
Primary completion
Dec 31, 2029
Completion
Dec 31, 2030

Study Design

Enrollment
126 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: IP-001
    1.0% IP-001 for injection immediately following local ablation or surgical resection and local ablation
  • Active Comparator: Control
    Local ablation or surgical resection and local ablation alone

Primary Outcome Measure

Recurrence Free Survival [ Time Frame: From Date of Randomization until date of documented progression, assessed up to 60 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of LouisvilleLouisvilleKentucky40202
Robert Martin, MD, PHD
[email protected]
502-629-3355
Robert Martin, MD, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Louisville, KY

By condition
Liver cancer
By specialty
OncologyGI oncologyHepatology
By research site
University of Louisville· Louisville, KY

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