Phase 2 Liver Cancer Trial, Recruiting NCT06349980 Sponsor: Shanghai Henlius Biotech Condition: Liver Cancer
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Phase 2 Liver Cancer Trial, Recruiting

NCT06349980
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 are willing to take part in clinical research, who fully understand the study, and who are able to sign a consent form and complete all required procedures
  • People who are 18 years of age or older at the time of signing the consent form
  • People who have been diagnosed with liver cancer (hepatocellular carcinoma, or HCC) — either through established clinical standards (for those with cirrhosis) or through a tissue biopsy (for those without cirrhosis)
  • People who have not previously received any systemic (whole-body) treatment for their liver cancer
  • People whose liver cancer is classified as Barcelona Clinic Liver Cancer (BCLC) stage C, or BCLC stage B if local treatments are not considered suitable for them (confirm with trial site)
  • People who have at least one measurable area of cancer that has been assessed within 4 weeks before starting the study medication, following specific measurement guidelines (RECIST v1.1); this area should not have had prior local treatment, unless it has clearly grown since that treatment
  • People who can provide a tumour tissue sample for testing of a protein called PD-L1, if such a sample is available
  • People who have had bone-related radiation therapy completed at least 4 weeks before starting the study medication, or a liver biopsy performed at least 1 week before, with any side effects from those procedures having largely resolved
  • People whose liver function has been assessed within 7 days before starting the study medication and falls within an acceptable range (Child-Pugh grade A, or grade B with a score of 7 or below)
  • People whose general physical ability, as measured by a standard scoring system (ECOG score), is rated 0 or 1 — meaning they are fully active or have only minor limitations — within 7 days before starting the study medication
  • People who are expected to live for at least 12 weeks
  • People who have adequate blood count and organ function results from laboratory tests

Who may not be able to join:

  • People who are known to have certain less common types of liver cancer, including hepatobiliary duct cell carcinoma, mixed cell carcinoma, or fibroblastic layer cell carcinoma
  • People who have a history of a condition where the liver fails to remove toxins from the blood (hepatic encephalopathy), or who have had a liver transplant, or who are preparing for or have previously had any organ or bone marrow transplant
  • People who have had serious bleeding from the upper digestive tract related to high blood pressure in the liver veins within the past 6 months, or who have certain vein abnormalities in the food pipe or stomach that carry a high bleeding risk, or who are considered by the study doctor to be at high risk of bleeding
  • People whose liver cancer has grown into the main branch of the portal vein (a major blood vessel), or has involved the large vein leading to the heart — though people with a blood clot in the main portal vein but with normal blood flow in the opposite branch may still be considered (confirm with trial site)
  • People who have brain or spinal cord lining (meningeal) spread of their cancer that is causing symptoms, has not been treated, or is getting worse
  • People who have had another cancer diagnosed within the past 2 years, not counting certain early-stage cancers that have been fully treated (such as some skin cancers, early cervical cancer, localised prostate cancer, breast ductal carcinoma in situ, or papillary thyroid cancer)
  • People who still need frequent draining (once a month or more) of fluid around the lungs, heart, or abdomen, even after appropriate treatment
  • People who have HIV infection
  • People who have active tuberculosis
  • People who have current or past lung conditions such as interstitial pneumonia, dust-related lung disease, radiation-related lung damage, or drug-related lung damage, or who have severely reduced lung function
  • People who have an active or suspected condition where the immune system attacks the body (autoimmune disease) — though people with thyroid conditions managed with hormone replacement, or with controlled type 1 diabetes managed with insulin, may still be considered
  • People who have had an active infection requiring antibiotic or antiviral treatment within 14 days before starting the study medication
  • People who have had signs of bleeding (such as coughing up blood or abnormal vaginal bleeding) during the screening period, a moderate bleeding event (Grade 2) within the past 3 months, or a serious bleeding event (Grade 3 or higher) within the past 6 months
  • People who have a known history of severe allergic reactions to any of the antibody medicines or ingredients used in this study
  • People who have previously been treated with immune checkpoint therapies (such as PD-1, PD-L1/2, or CTLA-4 inhibitors), bevacizumab or similar medicines, or anti-TIGIT therapies or related antibody treatments
  • People who, in the study doctor's judgement, have any other reason that makes participation in this trial unsuitable

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 8 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: Jia Fan, Fudan University

Phone: 021-64041990

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
Sponsor
Shanghai Henlius Biotech
Registry
ClinicalTrials.gov
Start date
5 August 2024
Est. completion
10 February 2027

Where this trial is recruiting

🇨🇳 China

Primary endpoints

ORR; 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: 8 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