Actively Recruiting
Adjuvant IP-001 Treatment for HCC Patients Following Surgical Resection and Ablation or Ablation Alone
Led by Robert C. Martin · Updated on 2025-09-30
126
Participants Needed
1
Research Sites
331 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Adjuvant IP-001 Treatment for HCC Patients Following Surgical Resection and Ablation or Ablation Alone
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 63; 18 years at time of signing Informed Consent.
- Diagnosed with hepatocellular carcinoma (HCC) confirmed by AASLD criteria or tumor biopsy.
- Planned treatment with curative ablation (RFA or MWA) or surgical resection plus ablation.
- HCC with intermediate, high, or very high risk of recurrence.
- Disease confined to the liver only, with no extra-hepatic lesions larger than 1 cm.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Past or ongoing hepatitis C infection eligible if treatment completed at least 1 month before Day 1.
- Controlled hepatitis B patients eligible if on antiviral therapy for at least 4 weeks with viral load under 500 IU/mL, or if anti-HBc positive with viral load under 500 IU/mL without need for prophylaxis.
- Adequate organ function confirmed by laboratory tests within 14 days prior to Day 1.
You will not qualify if you...
- Known allergy to shellfish, crabs, crustaceans, or any trial components.
- Active infection requiring systemic therapy.
- Diagnosis of immunodeficiency or current use of systemic steroids over 10 mg prednisone daily or other immunosuppressive therapy within 7 days before treatment.
- Active autoimmune disease requiring systemic treatment in past 2 years (excluding replacement therapies like thyroxine or insulin).
- History of allogenic tissue or solid organ transplant.
- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, active tuberculosis, or idiopathic pneumonitis.
- Received liver local therapy other than RFA or MWA (e.g., alcohol ablation, chemoembolization, radiation) less than 3 months before treatment.
- Use of prohibited therapies (antineoplastic chemotherapy, immunotherapy not in protocol, systemic glucocorticoids beyond allowed doses) less than 21 days before randomization.
- Received live vaccine within 28 days before treatment Day 1.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of Louisville
Louisville, Kentucky, United States, 40202
Actively Recruiting
Research Team
R
Robert Martin, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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