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

NCT06526338 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2025-09-30

No results posted yet for this study

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).

Conditions

Interventions

DRUG

1.0% IP-001 for injection

Participants will receive a single injection of 1.0% IP-001 following local ablation or surgical resection and local ablation

PROCEDURE

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)

PROCEDURE

Local Ablation Alone

Participants will have local ablation of the tumor by either radiofrequency ablation (RFA) or microwave ablation (MWA) alone

Sponsors & Collaborators

  • Robert C. Martin

    lead OTHER

Principal Investigators

  • Robert CG Martin, MD, PhD · University of Louisville

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-24
Primary Completion
2029-12-31
Completion
2030-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06526338 on ClinicalTrials.gov