Phase 2 Liver Cancer Trial, Recruiting NCT06261125 Sponsor: Mian XI Condition: Liver Cancer
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Phase 2 Liver Cancer Trial, Recruiting

NCT06261125
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 liver cancer (hepatocellular carcinoma), either confirmed by a tissue biopsy or by standard liver disease diagnostic guidelines
  • People who have cancer that has spread to lymph nodes in the abdomen, confirmed by CT or MRI scan, where the total size of the affected lymph nodes is no more than 10 cm, and at least one lymph node can be measured using standard criteria
  • People who have previously received local treatment for liver tumours or other cancer treatments, regardless of whether the cancer got worse afterwards
  • People with fewer than 3 active tumours in the liver, with a combined size of less than 10 cm, and no cancer spread outside the abdomen other than the abdominal lymph nodes (some involvement of the main liver blood vessel is allowed)
  • People who have never received a type of immunotherapy called PD-1/PD-L1 antibody treatment (Cohort 1), or people whose cancer got worse after receiving PD-1/PD-L1 antibody treatment (Cohort 2)
  • People aged between 18 and 75 years old at the time of diagnosis
  • People who are reasonably able to carry out daily activities, as assessed by a standard medical scale (ECOG score of 2 or less)
  • People whose liver is still functioning at a certain level, as measured by a standard scoring system (Child-Pugh class A)
  • People who have more than 700 ml of healthy liver volume remaining
  • People with a life expectancy of at least 12 weeks
  • People whose blood counts and organ function meet minimum required levels, including sufficient white blood cells, platelets, red blood cells, and acceptable liver and kidney function (confirm specific values with trial site)
  • People who are able to understand the study and agree to take part by signing a consent form

Who may not be able to join:

  • People whose liver cancer is of a widespread, diffuse type throughout the liver
  • People who previously tried lenvatinib or PD-1/PD-L1 antibody therapy but had to stop because they could not tolerate it
  • People whose cancer has spread to parts of the body outside the abdomen, other than the abdominal lymph nodes
  • People who have previously had radiation therapy to the abdomen
  • People with a known or suspected allergy or sensitivity to monoclonal antibody medications
  • People who have a pre-existing or ongoing bleeding disorder
  • People who are pregnant or currently breastfeeding
  • People who are unable to give informed consent due to psychological, family, social, or other reasons
  • People with a history of another type of cancer before joining the trial, with the exception of certain non-serious or previously cured cancers such as some skin cancers, early cervical cancer, or early prostate cancer that was fully treated
  • People who have had diabetes for more than 10 years and whose blood sugar levels are not well controlled
  • People who are unable to tolerate radiation therapy due to serious heart, lung, liver, or kidney problems, blood disorders, or severe weight loss and muscle weakness
  • People with active autoimmune diseases, a history of certain autoimmune conditions, immune deficiency conditions (including HIV), or a history of organ or bone marrow transplantation
  • People with a history of a lung condition called interstitial lung disease or non-infectious pneumonia
  • People with active tuberculosis in the past year, or a history of tuberculosis that was never properly treated
  • People with active hepatitis B or hepatitis C infections at levels above certain thresholds (confirm specific values with trial site)
  • People with any unstable health situation that could affect their safety or ability to follow the trial requirements

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 28 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: Mian Xi, MD, Sun Yat-sen University

Phone: +862087343385

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
Mian XI
Registry
ClinicalTrials.gov
Start date
10 March 2024
Est. completion
30 June 2026

Where this trial is recruiting

🇨🇳 China

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: 28 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