Phase 1 Liver Cancer Trial, Recruiting NCT06515314 Sponsor: Shanghai Ruiliyuan Biotechnology Co., Ltd. Condition: Liver Cancer
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Phase 1 Liver Cancer Trial, Recruiting

NCT06515314
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:

  • You are willing to read and sign a consent form agreeing to take part in the study.
  • You are between 18 and 75 years old.
  • You have a specific genetic marker called HLA-A 02:03 (this would be confirmed through a blood test).
  • You have been diagnosed with liver cancer (hepatocellular carcinoma) or another solid tumour that produces a protein called AFP, confirmed by a tissue sample, and surgery or local treatments are not expected to help you, and you have already tried at least one course of treatment.
  • Your tumour tissue samples or a blood test show a high level of the AFP protein.
  • Your liver cancer is at a certain stage of severity (Barcelona stage B or C) and your liver is functioning at an acceptable level (confirm with trial site).
  • You are generally well enough to carry out light activities and care for yourself (assessed using a standard scale).
  • Your doctors estimate you are likely to live for at least 4 more months.
  • You have at least one tumour that can be measured on a scan.
  • Your blood counts, liver function, kidney function, heart function, and oxygen levels are all within acceptable ranges (confirm with trial site for specific values).
  • If you could become pregnant, you must agree to use effective contraception throughout the trial and for at least 1 year after treatment, and have a negative pregnancy test before a blood collection procedure.

Who may not be able to join:

  • You still have significant side effects from a previous cancer treatment that have not cleared up or reduced to a mild level.
  • You have had another separate cancer diagnosis within the last 5 years (some exceptions may apply for certain early-stage cancers that were fully removed — confirm with trial site).
  • You have had a serious heart condition or a significant brain or nervous system disorder in the 6 months before joining the study.
  • You have an autoimmune disease (where your immune system attacks your own body) that requires long-term medication to suppress your immune system.
  • You have had an allergic reaction to the drugs cyclophosphamide or fludarabine, or are known to be allergic to any component used in this trial's treatment.
  • You have had, or currently have, a condition where the liver is unable to remove toxins from the blood, causing confusion or other brain-related symptoms (hepatic encephalopathy).
  • You have previously had an organ transplant or a transplant using cells from another person.
  • You have had bleeding in your stomach or intestines, or a significant risk of such bleeding, in the last 3 months.
  • You have a condition that causes problems with bleeding or blood clotting, whether inherited or developed over time.
  • You currently have an active infection or an unexplained fever.
  • You have cancer that has spread to your brain or nervous system and is causing symptoms.
  • You have a known HIV or syphilis infection, or an active hepatitis C infection.
  • You have hepatitis B with a virus level in your blood that is above a certain amount (confirm with trial site).
  • You are pregnant or breastfeeding, or a pregnancy test comes back positive before you join.
  • You have uncontrolled diabetes, or certain serious lung or liver conditions (confirm with trial site for details).

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 19 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.

Contact this trial

Principal Investigator: Xiaowu Huang, Doctor, Study Principal Investigator

Phone: 021-61049928

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 1
Sponsor
Shanghai Ruiliyuan Biotechnology Co., Ltd.
Registry
ClinicalTrials.gov
Start date
17 October 2024
Est. completion
10 August 2026

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Adverse events and serious adverse events; DLT

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: 19 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