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IP-001 for Liver Cancer
Phase 2
Recruiting
Led By Robert CG Martin, MD, PhD
Research Sponsored by Robert C. Martin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Has a treatment plan to receive either a curative ablation (RFA or MWA) or a curative surgical resection and ablation
Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
Must not have
Has an active infection requiring systemic therapy
Has had an allogenic tissue/solid organ transplant
Timeline
Screening 3 weeks
Treatment Varies
Follow Up months 12 and 24
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to assess if a single injection of IP-001 can be safe and effective as additional treatment after surgery or ablation for patients with liver cancer.
Who is the study for?
This trial is for individuals with hepatocellular carcinoma (HCC), a type of liver cancer, who have undergone surgical removal and/or local ablation of the tumor. Specific eligibility details are not provided.
What is being tested?
The study is testing the safety and effectiveness of a single injection called IP-001 as an additional treatment after either local tumor destruction or surgery plus local destruction in HCC patients.
What are the potential side effects?
Potential side effects of IP-001 are not detailed in the information provided. Typically, side effects from injections can include pain at the injection site, swelling, redness, and possible allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am scheduled for a procedure to remove or destroy my tumor completely.
Select...
I am fully active or can carry out light work.
Select...
My liver cancer is at a high risk of coming back.
Select...
My liver cancer is only in my liver, with no large tumors outside it.
Select...
I have been diagnosed with liver cancer through imaging or biopsy.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am currently being treated for an infection.
Select...
I have received an organ or tissue transplant from another person.
Select...
I have a history of lung conditions or active tuberculosis.
Select...
I am not on high-dose steroids or have an immune deficiency.
Select...
I haven't taken any disallowed medications in the last 21 days or 5 half-lives before joining.
Select...
I have been treated for an autoimmune disease in the last 2 years.
Select...
I have not received a live vaccine in the last 28 days.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ months 12 and 24
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~months 12 and 24
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Recurrence Free Survival
Secondary study objectives
Cancer Free Survival
Overall Survival
Overall Survival Rate
+3 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: IP-001Experimental Treatment3 Interventions
1.0% IP-001 for injection immediately following local ablation or surgical resection and local ablation
Group II: ControlActive Control2 Interventions
Local ablation or surgical resection and local ablation alone
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Who is running the clinical trial?
Robert C. MartinLead Sponsor
2 Previous Clinical Trials
69 Total Patients Enrolled
Robert CG Martin, MD, PhDPrincipal InvestigatorUniversity of Louisville
2 Previous Clinical Trials
90 Total Patients Enrolled
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