Phase 2 Liver Cancer Trial, Recruiting NCT07052253 Sponsor: Akeso Condition: Liver Cancer
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Phase 2 Liver Cancer Trial, Recruiting

NCT07052253
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 aged 18 to 75 years
  • People whose liver cancer has been confirmed through a tissue or cell sample, or who meet the accepted medical standards for diagnosing liver cancer without a biopsy
  • People whose cancer is classified as BCLC stage C, or BCLC stage B where the treating doctor has determined that curative local treatment is not appropriate
  • For two specific groups in this trial (Cohorts A and B): people who have not previously had any systemic (whole-body) drug treatment for their liver cancer
  • People who have at least one tumour that can be measured using standard imaging guidelines (RECIST v1.1)
  • People whose liver is functioning at an acceptable level, based on a standard liver scoring system (Child-Pugh score of 7 or below), and who are in reasonably good general health (ECOG score of 0 or 1)
  • People with hepatitis B (HBV) or hepatitis C (HCV) infection that is medically manageable
  • People whose organs and bone marrow are functioning well enough to safely participate

Who may not be able to join:

  • People whose liver cancer is of a specific rare type, such as fibrolamellar, sarcomatoid hepatocellular carcinoma, or cholangiocarcinoma
  • People who have been diagnosed with another cancer within the past 3 years
  • People with a history of hepatic encephalopathy (a condition where the brain is affected by liver failure)
  • People with significant fluid around the heart, or with fluid around the lungs requiring drainage, or with uncontrolled fluid build-up in the abdomen
  • People who are currently infected with both hepatitis B and hepatitis C at the same time
  • People whose cancer has spread to the brain or the membranes surrounding the brain or spinal cord
  • People who have had bleeding from varices (enlarged veins in the oesophagus or stomach) within the past 6 months, or where imaging shows cancer near major blood vessels with a high bleeding risk as assessed by the treating doctor
  • People whose liver tumour takes up more than 50% of the total liver volume, or where there are specific types of tumour blockages in major blood vessels, including the portal vein, mesenteric vein, or inferior vena cava, or where the heart is involved
  • People who have received local liver cancer treatment, any systemic anti-cancer drugs, or other clinical trial medications within the 4 weeks before starting the trial
  • People who are unable to swallow, or who have serious digestive tract problems, or who have had a bowel obstruction or bowel perforation within the past 6 months
  • People with uncontrolled high blood pressure, heart failure with symptoms, poorly controlled heart rhythm problems, heart muscle inflammation or disease, or a history of dangerous heart rhythm conditions
  • People with serious bleeding tendencies or blood clotting disorders
  • People with active tuberculosis, active syphilis, or a history of HIV infection
  • People who have had a serious infection in the 4 weeks before starting the trial, or who have received systemic antibiotic or antiviral treatment within the past 14 days
  • People who, in the treating doctor's judgement, have other medical conditions that make participation in the trial unsuitable (confirm with trial site)

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 14 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: (0760)89873999

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
Akeso
Registry
ClinicalTrials.gov
Start date
18 July 2025
Est. completion
10 May 2027

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Objective Response Rate (ORR)

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: 14 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