Back to search results

Adjuvant IP-001 Treatment for Liver Cancer After Surgery or Ablation

This study is looking at a treatment called 1.0% IP-001 for people with hepatocellular carcinoma (HCC), a type of liver cancer. You might be able to join if you are at least 18 years old, have HCC, and are planning to have surgery to remove the tumor along with local ablation (a procedure like RFA or MWA that uses heat to destroy cancer cells) or local ablation alone. The study is testing if a single injection of 1.0% IP-001 given after these procedures can help prevent the cancer from coming back. Researchers will track how long participants live without their cancer returning for up to 60 months. The current status of this study is unclear, and it plans to enroll 126 participants.

Study design
This is a Phase 2, two-armed, randomized study designed to compare 1.0% IP-001 with standard treatments. It plans to enroll 126 participants.
What's involved
Participants will receive a single injection of 1.0% IP-001 following local ablation or surgical resection and local ablation.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed from the date of randomization until documented progression, assessed up to 60 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06526338

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Robert C. Martin
~315 participants
Updated 2026-09-04 on ClinicalTrials.gov
What's tested:1.0% IP-001 for injectionSurgical Resection and Local AblationLocal Ablation Alone

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Recurrence Free Survival
Measured over From Date of Randomization until date of documented progression, assessed up to 60 months

Conditions

Hepatocellular Carcinoma

Explore related trials

Hepatocellular Carcinoma

NCT06526338

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • University of Louisville

    Louisville, Kentuckystudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Robert CG Martin, MD, PhD · PRINCIPAL_INVESTIGATOR · University of Louisville

Who to contact

Robert Martin, MD, PhD
[email protected]
502-629-3355
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Want this trial checked against your situation?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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 a curative ablation (MWA only) or a curative surgical resection and ablation, or where the patient may benefit from surgery and ablation or ablation prior to receiving anti-cancer therapy.
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 patient meets the following criteria:
Patients who are not exposed to unreasonable risks by continued use of the investigational agent in spite of progression of disease. Such criteria may include the following:
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.
Patients receiving retreatment with IP-001 following intrahepatic recurrence must satisfy all of the following:
Radiographic recurrence remains amenable to curative-intent thermal ablation.
No symptomatic rapid disease progression requiring urgent systemic therapy or palliative intervention.
ECOG performance status remains 0-2.
No evidence of clinically significant hepatic decompensation.
No extrahepatic disease that would preclude additional local therapy.
The Investigator determines that additional thermal ablation remains clinically appropriate.
The patient continues to satisfy protocol safety requirements.

Exclusion

Known allergic reaction to shellfish, crabs, crustacean, or any trial components used in trial treatment.
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 allogeneic tissue/solid organ transplant, or eligible for a liver transplant and/or on the liver transplantation waiting list.
History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, active tuberculosis, or idiopathic pneumonitis.
Has received local therapy to the liver, ablation other than 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:
Has received a live vaccine within 28 days prior to treatment Day 1.
Development of symptomatic extrahepatic disease.
ECOG \>2 attributable to cancer progression.
Rapid multifocal progression requiring systemic therapy.
Investigator determination that further local therapy is unlikely to provide meaningful clinical benefit.
Withdrawal of consent.

What this trial measures

  • Recurrence Free SurvivalFrom Date of Randomization until date of documented progression, assessed up to 60 months

    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