Phase 2 Liver Cancer Trial, Recruiting NCT05620771 Sponsor: Northwestern University Condition: Liver Cancer
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Phase 2 Liver Cancer Trial, Recruiting

NCT05620771
Recruiting Phase 2

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 who have been diagnosed with hepatocellular carcinoma (a type of liver cancer) confirmed according to recognised medical guidelines, with liver function falling within a specific accepted range (called Child-Pugh score A or B7).
  • People who have at least one tumour that can be measured using standard imaging guidelines (called RECIST). A previously treated area may count if it has clearly grown back and can be measured.
  • People who are new to treatment for this cancer, or who have already received any number of prior treatments — however, prior immunotherapy treatment for any other type of cancer is not permitted.
  • Adults aged 18 or older, of any gender.
  • People whose general physical functioning falls within an accepted range on a standard medical scale (called ECOG performance status 0, 1, or 2), meaning they are able to carry out at least some daily activities.
  • People whose blood counts, kidney function, liver function, and clotting levels meet specific minimum thresholds as determined by blood tests prior to joining the trial (confirm specific values with the trial site).
  • Women who could become pregnant and sexually active men who have not had sterilisation procedures must agree to use two forms of contraception during treatment and for 90 days after the last dose, and must also agree not to donate eggs or sperm and not to breastfeed during that period.
  • Women who could become pregnant must have a negative pregnancy test before joining the trial.
  • People who are able to understand the study and are willing to sign a written consent form before joining.

Who may not be able to join:

  • People who are currently taking part in another interventional clinical trial (trials that are purely observational, or in a follow-up phase only, may be acceptable — confirm with the trial site).
  • People who have received another experimental treatment within 28 days before joining.
  • People who have a history of severe allergic reactions to substances similar to the treatments used in this trial (which include Y-90, PD-1/PD-L1 inhibitors, and TKI medications), or a history of a severe life-threatening allergic reaction to any unknown substance.
  • People who have previously been treated with a PD-1 or PD-L1 inhibitor (a specific type of immunotherapy drug).
  • People who have had another cancer that was actively growing or required treatment within the last 3 years — though some exceptions apply, such as certain early-stage or fully treated skin cancers, or cancers that have been in complete remission for at least three years (confirm with the trial site).
  • People with an active autoimmune disease, or a history of one that could return and affect vital organs or require long-term immune-suppressing medication, including corticosteroids taken for one month or longer.
  • People whose kidneys have failed and who are currently on dialysis of any kind.
  • People who have untreated cancer that has spread to the brain or spinal cord — though people whose brain metastases were previously treated and have been stable for at least 6 weeks, and who do not require steroid medication for symptoms, may be considered (confirm with the trial site).
  • People with chronic Hepatitis B who still have detectable levels of the virus actively replicating in their blood above a specific threshold (confirm details with the trial site).
  • People with a known history of HIV who are not currently on effective HIV treatment.
  • People with a known history of Hepatitis C who have not been treated and cured — though people currently on Hepatitis C treatment with undetectable virus levels may be considered (confirm with the trial site).
  • People who have received chemotherapy, biologic therapy, or hormonal cancer treatment within 28 days before joining. Hormonal treatments for non-cancer conditions (such as insulin for diabetes) are acceptable.
  • People who still have unresolved side effects from a previous cancer treatment that have not reduced to a mild or absent level, with some exceptions (confirm with the trial site).
  • People who have received radiation therapy within 14 days before joining.
  • People who have received a live vaccine within 28 days before joining.
  • People who have taken systemic steroid (glucocorticoid) medication within 48 hours before joining — topical steroids and local injections may be acceptable if medically needed.
  • People with significant heart disease, including moderate-to-severe heart failure, unstable or new chest pain, or a heart attack within the past 180 days.
  • People who have had major surgery within 4 weeks before joining.
  • People who have previously had any type of organ or tissue transplant.
  • People who are currently pregnant or breastfeeding.
  • People who have another serious illness that is not currently under control.
  • People with active alcohol or drug use, or a psychiatric condition that, in the opinion of the trial doctor, would prevent safe participation in 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 2: approximately ~30% 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: Aparna Kalyan, MD, Northwestern University

Phone: 3126951301

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 2
Registry
ClinicalTrials.gov
Start date
30 November 2022
Est. completion
1 July 2040

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Progression Free Survival (PFS)

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