RecruitingHepatocellular Carcinoma
Adjuvant IP-001 Treatment for HCC Patients Following Surgical Resection and Ablation or Ablation Alone
Eligible age
18+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
See if you qualify for this study
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About this study
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).
Sponsor: Robert C. Martin
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:
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:
Where it's recruiting
Kentucky
Louisville
Source: ClinicalTrials.gov · NCT06526338 · last updated 2025-09-30