Phase 1 Liver Cancer Trial, Recruiting NCT05240950 Sponsor: Changhai Hospital Condition: Liver Cancer
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Phase 1 Liver Cancer Trial, Recruiting

NCT05240950
Recruiting Phase 1

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 to 75 years old, of any gender
  • People who have been diagnosed with colorectal cancer that has spread to the liver, had surgery to remove the original colorectal cancer, and had complete surgical removal of the liver spread (and any other organ involvement), with no visible or measurable remaining cancer found on scans after surgery
  • People whose original tumour and liver tumour samples show a protein called CEA present in more than 50% of the tumour cells, confirmed by laboratory testing
  • People with a life expectancy of at least 6 months
  • People who have a reasonable level of physical functioning, based on standard medical scoring scales (confirm with trial site for specific score details)
  • People who still have a positive result — or have tested positive again — on a specific blood test called ctDNA MRD, after completing chemotherapy (including any chemotherapy given before surgery)
  • People whose heart, liver, kidneys, and lungs are functioning at an acceptable level based on specific blood and clinical tests (confirm with trial site for exact thresholds)
  • People from whom a sufficient sample of blood cells called mononuclear cells can be safely collected from a vein
  • People of childbearing age who have no plans to become pregnant within one year after the cell treatment and who are using effective contraception

Who may not be able to join:

  • People with a history of serious diseases affecting the brain or central nervous system
  • People who have remaining or visible cancer on scans, or cancer in other tissues or organs that cannot be surgically removed
  • People with serious non-cancer illnesses, including autoimmune conditions, primary immune system disorders, or chronic breathing problems that block or restrict airflow
  • People who have previously received CAR-T cell therapy or any other treatment involving genetically modified T cells
  • People who participated in another clinical trial within 30 days before screening, or who plan to join another clinical trial during this study
  • People who have active Hepatitis B, active Hepatitis C, HIV, or syphilis infection at the time of screening
  • People with an infection that cannot be controlled
  • People who have another type of cancer in addition to their colorectal cancer and its spread
  • People who may need to take Chinese herbal medicines, steroid medications (taken throughout the body), or other immune-suppressing medications within 2 weeks before joining or during the trial, as these may affect the immune cells used in the treatment
  • People who are pregnant or breastfeeding
  • People with severe stomach or intestinal inflammation, such as severe gastric ulcers or severe ulcerative colitis
  • People with serious breathing or lung disease
  • People who cannot provide enough tumour tissue samples (at least 3 slides) for a type of genetic testing called next-generation sequencing (NGS)
  • People whom the trial investigators consider unsuitable for the study for any other reason

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 21 July 2026
Phase 1: approximately ~10% 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.

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Trial details

Status
Recruiting
Phase
Phase 1
Sponsor
Changhai Hospital
Registry
ClinicalTrials.gov
Start date
25 August 2022
Est. completion
25 December 2023

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Security (Incidence and severity of adverse events); Effectiveness (minimal residual disease); Efficacy (recurrence-free survival)

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: 21 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