Phase 1 Liver Cancer Trial, Recruiting NCT06307925 Sponsor: HC Biopharma Inc. Condition: Liver Cancer
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Phase 1 Liver Cancer Trial, Recruiting

NCT06307925
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 who are willing to take part voluntarily, understand the study procedures, and sign a consent form
  • Adults aged 18 to 75 years, of any gender
  • People who have been diagnosed with an advanced solid tumour (confirmed by laboratory testing of tissue or cells) whose cancer has not responded to standard treatments, or for whom no standard treatment is available
  • People who have at least one tumour that can be measured using standard imaging criteria (called RECIST v1.1)
  • People who are generally well enough to carry out light activity — rated 0 or 1 on a standard health performance scale (ECOG)
  • People with liver cancer (hepatocellular carcinoma) whose liver function scores at a certain level or below on the Child-Pugh scale (score of 7 or less)
  • People whose doctors estimate they are likely to live for at least 3 more months
  • People whose blood counts and organ function (including liver, kidneys, and heart/lungs) meet specific minimum levels as determined by blood tests
  • People who are able to provide a tumour tissue sample (either freshly collected or previously stored) for research testing, where possible
  • People who are capable of having children (male or female) must agree to use effective contraception from signing the consent form until at least 90 days after the last dose of the study drug; women capable of becoming pregnant must have a negative blood pregnancy test within 7 days before the first dose

Who may not be able to join:

  • People who have received another clinical trial treatment, chemotherapy, radiotherapy, or similar systemic cancer treatment within 28 days (or 5 half-lives of that treatment, whichever is shorter) before the first dose; or who have used herbal or Chinese medicines with anti-tumour purposes within 2 weeks before the first dose
  • People who had surgery or a serious injury within 4 weeks before the first dose
  • People who have been taking high-dose steroid medications (such as prednisone above 10 mg/day or a similar amount of another steroid) or other immune-suppressing medicines within 2 weeks before the first dose
  • People who have received immune-system-modifying drugs within 2 weeks before the first dose
  • People who received a live vaccine within 4 weeks before the first dose
  • People who have previously been treated with certain targeted cancer therapies, specifically those that work against PD-1, PD-L1, CTLA-4, or VEGF (confirm with trial site if unsure whether a prior treatment falls into these categories)
  • People who still have unresolved side effects from previous cancer treatments that have not improved to a mild level (Grade 1 or lower on a standard medical scale)
  • People who had to permanently stop a previous immunotherapy due to immune-related side effects, or who experienced severe (Grade 3 or higher) side effects from a previous anti-blood-vessel-growth therapy
  • People who have previously had a bone marrow transplant or an organ transplant from another person
  • People with active cancer spread to the brain, cancer spread to the lining of the brain or spinal cord, spinal cord compression, or a related condition called molluscum contagiosum disease
  • People who have had another separate cancer diagnosed within the past 5 years — with exceptions for certain skin cancers, papillary thyroid cancer, or pre-cancerous conditions that were fully treated
  • People with an active autoimmune disease, or a history of autoimmune disease
  • People with certain active infections, including active hepatitis B or C (with some exceptions based on specific test results — confirm with trial site), HIV/AIDS, active syphilis, active tuberculosis, or any active infection within 2 weeks before the first dose
  • People with serious unstable health conditions, including severe heart or blood vessel disease, or fluid build-up around the lungs, heart, or abdomen that requires repeated draining
  • People with serious bleeding problems or blood clotting disorders
  • People with a history of non-infectious lung inflammation or scarring that required steroid treatment
  • People who are pregnant or breastfeeding
  • People whom the trial doctor considers unsuitable for the study for any reason
  • People who have previously had a serious allergic reaction to any ingredient in the study drug HC010

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 26 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

Phone: +86 21 5043 3368

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
HC Biopharma Inc.
Registry
ClinicalTrials.gov
Start date
27 March 2024
Est. completion
31 December 2025

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Incidence of dose-limiting toxicity; Adverse events; serious adverse events; Maximum Tolerated Dose; Recommended Dose for Phase II Clinical Studies

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: 26 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