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RECRUITING
NCT06526338
PHASE2

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

Sponsor: Robert C. Martin

View on ClinicalTrials.gov

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).

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

126

Start Date

2024-07-24

Completion Date

2030-12

Last Updated

2025-09-30

Healthy Volunteers

No

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

Locations (1)

University of Louisville

Louisville, Kentucky, United States