Phase 2 Liver Cancer Trial, Recruiting NCT07536789 Sponsor: Fudan University Condition: Liver Cancer
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Phase 2 Liver Cancer Trial, Recruiting

NCT07536789
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 given written agreement to take part in the study.
  • People aged 18 or older at the time of joining the study.
  • People who have been diagnosed with liver cancer (hepatocellular carcinoma, or HCC) that has spread or cannot be surgically removed, confirmed either through a tissue sample or through established liver disease diagnostic standards.
  • People whose liver cancer has continued to grow or spread after receiving at least one treatment regimen that included a type of immunotherapy drug known as a PD-1 or PD-L1 inhibitor.
  • People who can provide a stored or freshly collected tumour tissue sample for laboratory testing to measure a specific protein called EGFR.
  • People who have at least one tumour that can be measured using standard imaging criteria (RECIST v1.1), which has either not been treated locally before, or has grown again after a previous local treatment.
  • People whose liver function falls within a specific scoring range (Child-Pugh score of 5–7) and whose general physical functioning meets a certain level (ECOG performance status of 2 or below).
  • People with a long-term hepatitis B infection whose virus levels are below a specific threshold at screening, and who are already receiving antiviral treatment according to standard guidelines in their region.
  • People with a life expectancy of at least 12 weeks.
  • People whose blood counts, liver enzyme levels, and kidney function all fall within the specific ranges required by the trial (confirm with trial site for exact values).
  • People who can take a pregnancy test within 7 days before starting the trial, if there is any possibility of pregnancy, and receive a negative result.
  • People who are willing and able to follow the study schedule, including attending appointments, following contraception requirements, and completing all required examinations and follow-up visits.

Who may not be able to join:

  • People whose liver cancer is a specific less common type, including fibrolamellar HCC, sarcomatoid HCC, or a mixed liver and bile duct cancer.
  • People who are on a liver transplant waiting list or who have advanced liver disease beyond the trial's criteria.
  • People with a history of significant heart disease, or who have had a serious gastrointestinal bleed within the 4 weeks before starting the study.
  • People who have experienced a blood clot or blockage in a blood vessel — such as a stroke, mini-stroke, deep vein thrombosis, or pulmonary embolism — within the 6 months before the first dose (with one specific exception around portal vein clots — confirm with trial site).
  • People who have or have had a second type of cancer, unless it was an early-stage skin cancer or a localised cervical condition that has been fully treated.
  • People with a weakened immune system, including those who are known to be HIV-positive.
  • People who have taken part in another clinical trial using an experimental treatment within the last 30 days before joining, or within a longer period depending on how long the previous trial drug stays in the body, whichever is longer.
  • People with certain other health conditions or complications that the trial doctor believes would affect the safety or results of the study, including: a history of lung scarring or inflammation; having both hepatitis B and hepatitis C at the same time; a history of acute or chronic pancreas inflammation; active tuberculosis; any other active infection requiring treatment; a history of receiving a transplanted organ or tissue; a diagnosis of immune deficiency, or use of steroid or immune-suppressing medication within 7 days before the first dose; an active autoimmune condition requiring treatment within the past 3 months, or a history of a severe autoimmune disease (some specific conditions such as vitiligo, stable thyroid conditions, type 1 diabetes, and certain skin or asthma conditions may still be eligible — confirm with trial site); receipt of a live vaccine within 30 days before or during the trial; or a history of cancer that has spread to the brain or spinal cord, unless it was previously treated, is no longer causing symptoms, and has not required steroid treatment for at least 6 weeks (confirm with trial site).
  • People taking medications known to interfere with the drugs being used in this trial.
  • People who are receiving any other active cancer treatment at the time of starting the study, other than what the trial specifies.
  • People who have received any other experimental treatment within 28 days before joining the study.
  • People who are pregnant, breastfeeding, or people of reproductive potential who are not using a highly effective method of contraception (acceptable methods include implants, injectable contraceptives, combined oral contraceptives, hormonal intrauterine devices, complete sexual abstinence, or a partner who has had a vasectomy).
  • People with a significant history of not following medical treatment plans, or who are unable to give reliable informed consent.

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 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

Phone: 8621-64041990

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
Registry
ClinicalTrials.gov
Start date
17 April 2026
Est. completion
15 April 2028

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Objective Response Rate (ORR) in Cohort 1.

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