Phase 2 Liver Cancer Trial, Recruiting NCT06986785 Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. Condition: Liver Cancer
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Phase 2 Liver Cancer Trial, Recruiting

NCT06986785
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 sign a consent form and follow the study requirements
  • People of any gender aged 18 to 75 years old
  • People with a life expectancy of at least 3 months
  • People diagnosed with advanced liver cancer (hepatocellular carcinoma) confirmed by a tissue or cell sample test
  • People willing to provide stored or fresh tumour tissue samples from a primary or secondary tumour site
  • People whose cancer has at least one measurable tumour, as defined by standard imaging measurement guidelines
  • People with a physical performance score of 0 or 1 on the ECOG scale, meaning someone who is fully active or restricted in strenuous activity but able to carry out light work (confirm with trial site)
  • People whose side effects from previous cancer treatments have mostly resolved to a mild level or better
  • People with healthy heart function, with the heart pumping at least 50% of its capacity
  • People whose organ function meets the study's required levels (confirm with trial site for specific details)
  • People with blood clotting results within acceptable ranges as measured by INR and APTT tests
  • People with low to moderate levels of protein in their urine
  • People with no liver cirrhosis, or only mild cirrhosis classified as Child-Pugh A
  • People who have had a blood test confirming their hepatitis B virus status, whether positive or negative
  • Women of childbearing age who test negative for pregnancy within 7 days before starting treatment and are not breastfeeding; all participants must use adequate contraception throughout treatment and for 6 months after it ends

Who may not be able to join:

  • People with active cancer that has spread to the brain or central nervous system
  • People who have taken part in another clinical trial within the 4 weeks before joining this study
  • People who have received chemotherapy, radiotherapy, or biological cancer therapy within 4 weeks before the first study dose
  • People who have had major surgery within 4 weeks before the first study dose
  • People who have needed corticosteroid or immune-suppressing medication within 2 weeks before starting the study
  • People with significant lung disease, or a history of lung inflammation that required steroid treatment
  • People who had a serious infection affecting the whole body within 4 weeks before screening
  • People with an active autoimmune disease or a history of autoimmune disease
  • People who have had another type of cancer within the 5 years before starting treatment
  • People who test positive for HIV, have active tuberculosis, or have active hepatitis C infection
  • People with high blood pressure that remains poorly controlled despite taking two different blood pressure medications
  • People with diabetes that is not well managed
  • People with a history of serious heart or stroke-related conditions
  • People who have previously had a stem cell, bone marrow, or organ transplant
  • People who have had significant or clinically concerning bleeding within the 4 weeks before screening
  • People with large or symptomatic fluid build-up in body cavities that is not well controlled
  • People whose imaging scans show the tumour has grown into or wrapped around major blood vessels in the chest, neck, or throat, or has invaded the heart or its surrounding sac
  • People who have had an unstable blood clot requiring treatment within the 6 months before screening
  • People who have previously been treated with a specific type of drug called an ADC that uses a topoisomerase I inhibitor (confirm with trial site for specific drug details)
  • People with a known allergy to recombinant humanised antibodies or to any ingredients in the trial drug
  • People who received a high cumulative dose of anthracycline chemotherapy drugs in prior treatment
  • Women who are pregnant or breastfeeding
  • People with a history of substance abuse involving psychotropic drugs that cannot be resolved, or people with a mental health disorder
  • People the study investigator considers unsuitable for the trial for any other reason

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 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: 15013238943

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

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Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
Sichuan Baili Pharmaceutical Co., Ltd.
Registry
ClinicalTrials.gov
Start date
24 June 2025
Est. completion
1 May 2027

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Objective Response Rate (ORR); Recommended Phase II Dose (RP2D)

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