Phase 3 Liver Cancer Trial, Recruiting NCT06007846 Sponsor: Inova Health Care Services Condition: Liver Cancer
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Phase 3 Liver Cancer Trial, Recruiting

NCT06007846
Recruiting Phase 3

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People aged 18 or older.
  • People with a new diagnosis of liver cancer (hepatocellular carcinoma) that has not yet been treated, confirmed by tissue sample or imaging, with at least one tumour that can be measured using standard imaging guidelines. A previous liver cancer treated with surgery or radiation is allowed, as long as it was at least 2 years before the current diagnosis.
  • People whose cancer has been assessed by a specialist team panel as locally advanced and not suitable for surgical removal.
  • People with a liver cirrhosis severity score of Child-Pugh B7 or higher, who are considered not suitable for intensive cancer drug treatment (confirm with trial site).
  • People with a general health and activity level rated between 0 and 2 on a standard medical scale (meaning able to carry out some daily activities, even if limited).
  • People with adequate blood counts and organ function, as confirmed by testing.
  • Sexually active male participants with a partner who could become pregnant must agree to use an accepted and effective form of contraception throughout the study period, as the study drug (Memantine) is known to be harmful to a developing baby.
  • Female participants who could become pregnant must have a negative blood pregnancy test within 24 hours before starting treatment, and must agree to use an accepted and effective form of contraception throughout the study period.
  • People who are willing and able to understand and sign a written consent form agreeing to take part.
  • Men and women of any race, ethnic group, or sexual orientation are eligible for this study.

Who may not be able to join:

  • People with a liver cirrhosis severity score classified as Child-Pugh A.
  • People who are pregnant or currently breastfeeding.
  • People with other existing illnesses or medical history that could interfere with safe participation or assessment in the study, as judged by the investigators.
  • People with a life-threatening illness occurring at the same time.
  • People who the medical team believes are unlikely to be able to follow the study requirements reliably.
  • People who are already enrolled in another interventional clinical trial.
  • People with active tuberculosis.
  • People with serious heart or blood vessel conditions — such as significant heart disease, a heart attack, or stroke within the past 3 months, or unstable heart rhythm or unstable chest pain.
  • People whose liver cancer is a specific rare type, including fibrolamellar HCC, sarcomatoid HCC, or a mixed liver and bile duct cancer.
  • People with pain caused by their tumour that is not well controlled. People who are on pain medication must have been on a stable dose for at least 10 days before joining.
  • People who have had a major surgical procedure, open biopsy, or serious physical injury within the 28 days before starting the study treatment.
  • People with cancer that has spread to the brain or nervous system, where symptoms are present, untreated, or actively getting worse.
  • People currently receiving other cancer treatments, with the exception of palliative radiation used for symptom relief, which is permitted during the study.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 27 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Arthur Winer, MD, Inova Health Care Service

Phone: 571-472-0615

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 3
Sponsor
Inova Health Care Services
Registry
ClinicalTrials.gov
Start date
31 July 2023
Est. completion
31 July 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Patients Progression Free Survival at 6 months

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov