Hepatocellular CarcinomaPhase 2NCT06526338
Adjuvant IP-001 Treatment for HCC Patients Following Surgical Resection and Ablation or Ablation Alone
A Phase 2 study testing 1.0% IP-001 for injection, Surgical Resection and Local Ablation and Local Ablation Alone in people with Hepatocellular Carcinoma, run by Robert C. Martin at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of administration of intratumoral IP-001 injection at different dosages (volume and concentration) following local microwave ablation (MWA) or surgical resection and ablation in patients with hepatocellular carcinoma (HCC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- 1.0% IP-001 for injection, Surgical Resection and Local Ablation and Local Ablation Alone
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 315 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jul 2024to Dec 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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:
- 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 500 IU/mL should stay on the same therapy throughout study treatment.
- 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.
- 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:
- Absence of symptoms and signs indicating clinically significant progression of disease.
- No decline in performance status, as measured by ECOG or Karnofsky or both.
- Absence of symptomatic rapid disease progression requiring urgent medical intervention.
- Ensure that patients are reconsenting to treatment with the Informed Consent clearly stating that retreatment is not standard of care.
- 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.
- Hematological: Absolute neutrophil count ≥1500/µL or ANC of ≤1500/µL if there is a stable medical history of neutropenia per provider discretion; Platelets ≥40,000/µL; Hemoglobin ≥8.0 g/dL.
- Renal: Creatinine OR measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl) ≤1.5 × ULN OR GFR ≥30 mL/min for patients with creatinine levels >1.5 × institutional ULN
- Hepatic: Total bilirubin ≤2 mg/dL OR direct bilirubin ≤ULN for patients with total bilirubin levels >2 mg/dL; AST (SGOT) and ALT (SGPT) ≤5 × ULN; Albumin (c) >2.6 g/dL
- Coagulation: International normalized ratio (INR) OR prothrombin time (PT) ≤1.5 × ULN unless patient is receiving anticoagulant therapy as long as PT is within therapeutic range of intended use of anticoagulants
- Retreatment Inclusion Criteria:
- 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.
Who cannot join
- 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.
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- 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:
- 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 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.
- Retreatment Exclusion Criteria:
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Louisville
Louisville, Kentucky, 40202
Robert Martin, MD, PHD, 502-629-3355, robert.martin@louisville.edu
Robert Martin, MD, PhD
About this study
Official title: 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
The purpose of this study is to evaluate the safety and efficacy of administration of intratumoral IP-001 injection at different dosages (volume and concentration) following local microwave ablation (MWA) or surgical resection and ablation in patients with hepatocellular carcinoma (HCC).
Read the detailed description
This is a Phase 2, five-armed, randomized study designed to evaluate the safety and efficacy of administration of intratumoral IP-001 injection at different dosages (volume and concentration) following local ablation or surgical resection and local ablation in patients with hepatocellular carcinoma who have an intermediate or high risk of recurrence compared to curative ablation or ablation and surgical resection.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- 1.0% IP-001 for injection, Surgical Resection and Local Ablation, Local Ablation Alone
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1.0% IP-001 for injectionDrug
Participants will receive intratumoral injection of 1.0% IP-001 following local microwave ablation or surgical resection and local microwave ablation
Surgical Resection and Local AblationProcedure or surgery
Participants will undergo surgical resection of the tumor and local microwave ablation
Local Ablation AloneProcedure or surgery
Participants will have local ablation of the tumor by microwave ablation alone
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Participants with ≤3 hepatic tumors that can be treated in one ablation session | Experimental | Participants will be randomized 1:1:1 to receive intratumoral injection of IP-001 (10 mg/mL, 4 mL [low volume]) immediately following local microwave ablation or surgical resection and local microwave ablation Receives: Drug: 1.0% IP-001 for injection; Procedure: Surgical Resection and Local Ablation; Procedure: Local Ablation Alone |
| Arm B: Participants with ≤3 hepatic tumors that can be treated in one ablation session | Active comparator | Participants will be randomized 1:1:1 to receive local microwave ablation or surgical resection and local microwave ablation alone Receives: Procedure: Surgical Resection and Local Ablation; Procedure: Local Ablation Alone |
| Arm C: Participants with ≤3 hepatic tumors that can be treated in one ablation session | Experimental | Participants will be randomized 1:1:1 to receive intratumoral injection of IP-001 (10 mg/mL, up to 12 mL [high volume]) immediately following local microwave ablation or surgical resection and local microwave ablation Receives: Drug: 1.0% IP-001 for injection; Procedure: Surgical Resection and Local Ablation; Procedure: Local Ablation Alone |
| Arm D: Participants with >3 hepatic tumors that can be treated in more than one ablation session | Experimental | Participants will be randomized 1:1 to receive intratumoral injection of IP-001 (10mg/mL [high concentration], up to 12 mL) immediately following local microwave ablation or surgical resection and local microwave ablation Receives: Drug: 1.0% IP-001 for injection; Procedure: Surgical Resection and Local Ablation; Procedure: Local Ablation Alone |
| Arm E: Participants with >3 hepatic tumors that can be treated in more than one ablation session | Experimental | Participants will be randomized 1:1 to receive intratumoral injection of diluted IP-001 (1 mg/mL [low concentration], up to 12 mL) immediately following local microwave ablation or surgical resection and local microwave ablation Receives: Drug: 1.0% IP-001 for injection; Procedure: Surgical Resection and Local Ablation; Procedure: Local Ablation Alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence Free Survival
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
Measured: From Date of Randomization until date of documented progression, assessed up to 60 months
Secondary outcomes (6)
Cancer Free Survival
Participants will be followed every 12 weeks from treatment Day 1 for the first 2 years, and every 24 weeks thereafter until disease related death.
Measured: Months 12 and 24
Overall Survival
Participants will be followed every 12 weeks from treatment Day 1 for the first 2 years, and every 24 weeks thereafter until death of any cause.
Measured: Months 12 and 24
Overall Survival Rate
Proportion of participants who have not experienced death from treatment Day 1 at 12 and 24 months after treatment.
Measured: Months 12 and 24
Recurrence Free Survival Rate
Assessed from treatment Day 1 to documentation of disease recurrence or extrahepatic) or death, whichever occurs first.
Measured: Months 12 and 24
Time to Intrahepatic Tumor Recurrence
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
Measured: From Date of Randomization until date of documented progression, assessed up to 60 months
Time to Extrahepatic Tumor Recurrence
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
Measured: From Date of Randomization until date of documented progression, assessed up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2024
- Study start24 Jul 2024
- Primary completionDec 2029 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 315 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Robert C. Martin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Robert C. Martin, University of Louisville
- Investigators
- Robert CG Martin, MD, PhD, Principal investigator, University of Louisville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06526338
- Sponsor's protocol ID
- 24.0321
- Status last verified
- Sep 2026
- First submitted
- 23 Jul 2024
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06526338
- Acronym / sponsor ID
- 24.0321
- Conditions
- Hepatocellular Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 315 participants (estimated)
- Lead sponsor
- Robert C. MartinUniversity, hospital or other
- Study start
- 24 Jul 2024 (actual)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 29 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety and efficacy of administration of intratumoral IP-001 injection at different dosages (volume and concentration) following local microwave ablation (MWA) or surgical resection and ablation in patients with hepatocellular carcinoma (HCC).
Detailed description
This is a Phase 2, five-armed, randomized study designed to evaluate the safety and efficacy of administration of intratumoral IP-001 injection at different dosages (volume and concentration) following local ablation or surgical resection and local ablation in patients with hepatocellular carcinoma who have an intermediate or high risk of recurrence compared to curative ablation or ablation and surgical resection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Arm A: Participants with ≤3 hepatic tumors that can be treated in one ablation session | Experimental | Drug: 1.0% IP-001 for injection, Procedure: Surgical Resection and Local Ablation, Procedure: Local Ablation AloneParticipants will be randomized 1:1:1 to receive intratumoral injection of IP-001 (10 mg/mL, 4 mL [low volume]) immediately following local microwave ablation or surgical resection and local microwave ablation |
| Arm B: Participants with ≤3 hepatic tumors that can be treated in one ablation session | Active comparator | Procedure: Surgical Resection and Local Ablation, Procedure: Local Ablation AloneParticipants will be randomized 1:1:1 to receive local microwave ablation or surgical resection and local microwave ablation alone |
| Arm C: Participants with ≤3 hepatic tumors that can be treated in one ablation session | Experimental | Drug: 1.0% IP-001 for injection, Procedure: Surgical Resection and Local Ablation, Procedure: Local Ablation AloneParticipants will be randomized 1:1:1 to receive intratumoral injection of IP-001 (10 mg/mL, up to 12 mL [high volume]) immediately following local microwave ablation or surgical resection and local microwave ablation |
| Arm D: Participants with >3 hepatic tumors that can be treated in more than one ablation session | Experimental | Drug: 1.0% IP-001 for injection, Procedure: Surgical Resection and Local Ablation, Procedure: Local Ablation AloneParticipants will be randomized 1:1 to receive intratumoral injection of IP-001 (10mg/mL [high concentration], up to 12 mL) immediately following local microwave ablation or surgical resection and local microwave ablation |
| Arm E: Participants with >3 hepatic tumors that can be treated in more than one ablation session | Experimental | Drug: 1.0% IP-001 for injection, Procedure: Surgical Resection and Local Ablation, Procedure: Local Ablation AloneParticipants will be randomized 1:1 to receive intratumoral injection of diluted IP-001 (1 mg/mL [low concentration], up to 12 mL) immediately following local microwave ablation or surgical resection and local microwave ablation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (29 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1.0% IP-001 for injectionParticipants will receive intratumoral injection of 1.0% IP-001 following local microwave ablation or surgical resection and local microwave ablation | Drug | Arm A: Participants with ≤3 hepatic tumors that can be treated in one ablation session, Arm C: Participants with ≤3 hepatic tumors that can be treated in one ablation session, Arm D: Participants with >3 hepatic tumors that can be treated in more than one ablation session, Arm E: Participants with >3 hepatic tumors that can be treated in more than one ablation session |
| Surgical Resection and Local AblationParticipants will undergo surgical resection of the tumor and local microwave ablation | Procedure or surgery | Arm A: Participants with ≤3 hepatic tumors that can be treated in one ablation session, Arm B: Participants with ≤3 hepatic tumors that can be treated in one ablation session, Arm C: Participants with ≤3 hepatic tumors that can be treated in one ablation session, Arm D: Participants with >3 hepatic tumors that can be treated in more than one ablation session, Arm E: Participants with >3 hepatic tumors that can be treated in more than one ablation session |
| Local Ablation AloneParticipants will have local ablation of the tumor by microwave ablation alone | Procedure or surgery | Arm A: Participants with ≤3 hepatic tumors that can be treated in one ablation session, Arm B: Participants with ≤3 hepatic tumors that can be treated in one ablation session, Arm C: Participants with ≤3 hepatic tumors that can be treated in one ablation session, Arm D: Participants with >3 hepatic tumors that can be treated in more than one ablation session, Arm E: Participants with >3 hepatic tumors that can be treated in more than one ablation session |
Primary outcome
Recurrence Free Survival
Time frame: From 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
6 secondary outcomes
Cancer Free Survival
Time frame: Months 12 and 24
Overall Survival
Time frame: Months 12 and 24
Overall Survival Rate
Time frame: Months 12 and 24
Recurrence Free Survival Rate
Time frame: Months 12 and 24
Time to Intrahepatic Tumor Recurrence
Time frame: From Date of Randomization until date of documented progression, assessed up to 60 months
Time to Extrahepatic Tumor Recurrence
Time frame: From Date of Randomization until date of documented progression, assessed up to 60 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Robert CG Martin, MD, PhD principal investigator
University of Louisville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 1.0% IP-001 for injection, Surgical Resection and Local Ablation and Local Ablation Alone in people with Hepatocellular Carcinoma, run by Robert C. Martin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 29 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Robert Martin, MD, PhD (502-629-3355, robert.martin@louisville.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence Free Survival (time frame: From Date of Randomization until date of documented progression, assessed up to 60 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.