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

NCT06526338 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 24.0321
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief 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

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• Recurrence 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

  From Date of Randomization until date of documented progression, assessed up to 60 months

Secondary Outcomes (6)

• Cancer Free Survival

  Months 12 and 24

• Overall Survival

  Months 12 and 24

• Overall Survival Rate

  Months 12 and 24

• Recurrence Free Survival Rate

  Months 12 and 24

• Time to Intrahepatic Tumor Recurrence

  From Date of Randomization until date of documented progression, assessed up to 60 months

Study Arms (2)

IP-001

EXPERIMENTAL

1.0% IP-001 for injection immediately following local ablation or surgical resection and local ablation

Drug: 1.0% IP-001 for injection; Procedure: Surgical Resection and Local Ablation; Procedure: Local Ablation Alone

Control

ACTIVE COMPARATOR

Local ablation or surgical resection and local ablation alone

Procedure: Surgical Resection and Local Ablation; Procedure: Local Ablation Alone

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

IP-001

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)

Control; IP-001

Local Ablation Alone PROCEDURE

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

Control; IP-001

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
• Patient with past or ongoing hepatitis C virus (HCV) infection will be eligible if the patient has completed HCV treatment at least 1 month prior to Day 1.
• Patient with controlled hepatitis B will be eligible if the patients meets the following criteria:
• Antiviral therapy for hepatitis B virus (HBV) must be given for at least 4 weeks and HBV viral load must be less than 500 IU/mL prior to treatment. Patients on active HBV therapy with viral loads under 00 IU/mL should stay on the same therapy throughout study treatment.
• Patients who are hepatitis B core antibody (anti-HBc) positive, negative for HBsAg, and negative or positive for anti- HBs, and who have an HBV viral load under 500 IU/mL do not require HBV anti-viral prophylaxis.
• Has adequate organ function as specified in the Adequate Organ Function Laboratory Values Table. Specimens must be collected within 14 days prior to Day 1.

You may not qualify if:

• Known allergic reaction to shellfish, crabs, crustacean, or any trial components.
• Has an active infection requiring systemic therapy.
• Has a diagnosis of immunodeficiency or currently receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent), or any other form of immunosuppressive therapy within 7 days prior to treatment day (Day 1), or has plans to start treatment including \>10 mg daily of prednisone equivalent or any immunotherapy.
• Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents or immunosuppressive drugs). NOTE: replacement therapy (e.g., thyroxine or insulin) is not considered a form of systemic treatment and is allowed.
• Has had an allogenic tissue/solid organ transplant.
• History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, active tuberculosis, or idiopathic pneumonitis.
• Has received local therapy to liver, ablation other than radiofrequency or microwave ablation (i.e., alcohol ablation, transcatheter chemoembolization, transcatheter embolization, hepatic arterial infusion, local radiation/Stereotactic Body Radiation Therapy or radioembolization) less than 3 months prior to treatment.
• Is receiving any of the following prohibited concomitant therapies less than 21 days from treatment or 5 drug elimination half-lives, whichever is shorter prior to randomization:
• Antineoplastic systemic chemotherapy or biological therapy.
• Immunotherapy not specified in this protocol.
• Systemic glucocorticoids for any purpose other than to modulate symptoms from an adverse event (AE) that is suspected to have an immunologic etiology. Inhaled or topical steroids are allowed, and systemic steroids at doses ≤10 mg/day prednisone or equivalent are allowed. Exception: steroids may be used for premedication prior to imaging.
• Has received a live vaccine within 28 days prior to treatment Day 1.

Sponsors & Collaborators

• Robert C. Martin: lead

Study Sites (1)

University of Louisville

Louisville, Kentucky, 40202, United States

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

N-dihydrogalactochitosan; Injections

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Robert CG Martin, MD, PhD

  University of Louisville

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Robert Martin, MD, PhD

CONTACT

502-629-3355; robert.martin@louisville.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of the Division of Surgical Oncology Robert C. Martin

Study Record Dates

• First Submitted: July 23, 2024
• First Posted: July 29, 2024
• Study Start: July 24, 2024
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2030
• Last Updated: September 30, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)