Study on IP-001 Treatment for Liver Cancer Patients After Surgery or Ablation

Sponsor: Robert C. Martin

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06526338

Provider View

This clinical trial is testing the safety and effectiveness of a single injection of IP-001 as an additional treatment for patients with liver cancer (HCC) who have undergone surgery or ablation to remove the cancer.

Patient Parameters

Program Overview

The study aims to find out if a single injection of IP-001 can help prevent the return of liver cancer (HCC) in patients who have already had surgery or ablation to remove the cancer. This treatment is being tested in patients who are at an intermediate or high risk of the cancer coming back.

Description

This is a Phase 2 study with two groups of patients. It is designed to test the safety and effectiveness of a single injection of IP-001 directly into the tumor area after patients have had surgery or ablation to treat liver cancer (HCC). The study is looking at whether this additional treatment can help prevent the cancer from returning in patients who are at a higher risk of recurrence.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Diagnosed with liver cancer (HCC) confirmed by imaging or biopsy.
  • Planned to receive either ablation (RFA or MWA) or surgery and ablation as treatment.
  • Have liver cancer with an intermediate, high, or very high risk of coming back.
  • Cancer is only in the liver, with no tumors outside the liver larger than 1 cm.
  • Have a performance status score of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • If previously infected with hepatitis C, must have completed treatment at least 1 month before starting the study.
  • If infected with hepatitis B, must have a low viral load and be on stable antiviral therapy.
  • Must have adequate organ function based on specific lab tests taken within 14 days before starting the study.

Exclusion Criteria

  • Allergic to shellfish, crabs, crustaceans, or any components of the trial.
  • Have an active infection needing treatment.
  • Have an immune deficiency or are on high-dose steroids or other immune-suppressing treatments.
  • Have an active autoimmune disease needing treatment in the past 2 years.
  • Have had a tissue or organ transplant.
  • Have certain lung diseases or active tuberculosis.
  • Have had other liver treatments less than 3 months before starting the study.
  • Are on certain cancer treatments or therapies less than 21 days before starting the study.
  • Have received a live vaccine within 28 days before starting the study.

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