Phase 2 Liver Cancer Trial, Recruiting NCT05257590 Sponsor: TaiRx, Inc. Condition: Liver Cancer
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Phase 2 Liver Cancer Trial, Recruiting

NCT05257590
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 aged 18 or older (20 or older for participants in Taiwan)
  • People who have been diagnosed with liver cancer (hepatocellular carcinoma), confirmed by a tissue sample, cell sample, or by specific imaging scans showing a liver tumour of 1 cm or larger
  • People whose liver cancer is at an advanced stage, cannot be removed by surgery, is not suitable for treatments that could cure it, and whose cancer has continued to grow or who could not tolerate earlier cancer treatments such as sorafenib, lenvatinib, or atezolizumab combined with bevacizumab
  • People whose liver cancer is classified as either BCLC stage B (where local treatments are no longer suitable or have stopped working) or BCLC stage C
  • People whose liver is still functioning at a level classified as Child-Pugh class A (a measure of liver health)
  • People whose cancer can be measured on scans, according to specific measurement guidelines (mRECIST)
  • People who are generally well enough to carry out light activity and care for themselves, rated 0 or 1 on a standard activity scale (ECOG)
  • People whose blood test results meet the required levels for liver enzymes, bilirubin, blood cell counts, kidney function, protein levels, and blood clotting (confirm specific values with the trial site)
  • People whose heart's electrical activity, measured on an ECG, falls within the required range (confirm with trial site)
  • People who have liver cancer related to a hepatitis B (HBV) or hepatitis C (HCV) infection; those with hepatitis B must be on antiviral medication with a low virus level, or must be willing to start antiviral treatment at the time of joining the trial

Who may not be able to join:

  • People whose liver cancer has spread into the main branch of the portal vein (a major blood vessel supplying the liver)
  • People with a known history of swollen veins in the oesophagus (varices) or any gastrointestinal bleeding in the past 3 months
  • People who have previously received immunotherapy treatment for their liver cancer
  • People who have had limited-area radiation therapy within 7 days, or broader radiation therapy within 28 days, before the planned start of treatment
  • People who have received other systemic cancer treatments within 14 days (or 5 half-lives of the drug) before the planned start of treatment
  • People who have had local treatments to the liver (such as trans-arterial embolisation or radiofrequency ablation) within 28 days before the planned start of treatment
  • People who have another active cancer that is likely to need treatment within the next two years or could affect the trial results
  • People who have an active bacterial or fungal infection requiring treatment within 7 days before the planned start of treatment
  • People with known cancer that has spread to the brain or spinal cord
  • People with a known history of HIV infection
  • People who are currently pregnant or breastfeeding
  • People with a known stomach or bowel condition that could significantly affect how oral medications are absorbed
  • People with a psychiatric illness or personal circumstances that would make it difficult to follow the trial requirements
  • People with a known history of significant heart or cardiovascular problems

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 14 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: Pei-Jer Chen, MD/PhD, National Taiwan University Hospital

Phone: 886-2-2653-5007

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
Sponsor
TaiRx, Inc.
Registry
ClinicalTrials.gov
Start date
23 May 2022
Est. completion
31 December 2026

Where this trial is recruiting

🇹🇼 Taiwan

Primary endpoints

Objective Response Rate (ORR)_mRECIST

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: 14 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