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New treatment option for Hepatocellular Carcinoma
Official title Adjuvant IP-001 Treatment for HCC Patients Following Surgical Resection and Ablation or Ablation Alone
ClinicalTrials.gov ID: NCT06526338
What this study is testing
What is 1.0% IP-001 for injection?
1.0% IP-001 for injection is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for hepatocellular carcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- 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.
You likely can't join 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...
- Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents or...
- 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...
See the full eligibility 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:
- 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...
- 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.
- 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...
- 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)...
- 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...
- 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...
- Has received a live vaccine within 28 days prior to treatment Day 1.
The study team makes the final eligibility decision.
Where it's taking place
- Louisville, Kentucky, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Louisville, Kentucky, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.