Treatment for liver cancer patients after surgery or ablation

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

This study is testing if a single injection of a new treatment called IP-001 can help prevent liver cancer from coming back in patients who have just had surgery or ablation.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 126 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Louisville (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy, radiation, prednisone
• Locations: 1 site (Louisville, Kentucky)
• Trial ID: NCT06526338 on ClinicalTrials.gov

What this trial studies

This Phase 2 clinical trial evaluates the safety and efficacy of a single injection of IP-001 as an adjuvant therapy for patients with hepatocellular carcinoma (HCC) following surgical resection or local ablation. The study is randomized and consists of two arms, comparing the outcomes of patients receiving IP-001 to those undergoing curative ablation or surgical resection without the injection. The goal is to determine if IP-001 can reduce the risk of cancer recurrence in patients at intermediate or high risk after their initial treatment.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with hepatocellular carcinoma at intermediate or high risk of recurrence who are undergoing curative treatment.

Not a fit: Patients with extra-hepatic lesions or those with a poor performance status may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the risk of recurrence in liver cancer patients after surgery or ablation.

How similar studies have performed: Other studies have shown promise with similar adjuvant therapies, but the specific use of IP-001 in this context is novel.

Eligibility criteria

Inclusion Criteria:

* 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:

  1. 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.
  2. 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.

Exclusion Criteria:

* 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:

  1. Antineoplastic systemic chemotherapy or biological therapy.
  2. Immunotherapy not specified in this protocol.
  3. 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.

Where this trial is running

Louisville, Kentucky

• University of Louisville — Louisville, Kentucky, United States (Recruiting)

Study contacts

• Principal investigator: Robert CG Martin, MD, PhD — University of Louisville
• Study coordinator: Robert Martin, MD, PhD

Conditions Hepatocellular Carcinoma