Phase 2 Liver Cancer Trial, Recruiting NCT07105748 Sponsor: Fudan University Condition: Liver Cancer
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Phase 2 Liver Cancer Trial, Recruiting

NCT07105748
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 consent to participate in the study.
  • People aged 18 or older at the time of joining the study.
  • People whose cancer cannot be treated with surgery or other local treatments aimed at a cure.
  • People who have had a biopsy confirming a specific type of liver cancer that has features of both hepatocellular carcinoma and cholangiocarcinoma (a mixed liver cancer).
  • People who have not previously had any systemic (whole-body) treatment for their liver cancer.
  • People who have at least one area of cancer that can be measured using a CT scan or MRI, according to standard measurement guidelines.
  • People whose liver function and general physical condition fall within specific acceptable ranges, as assessed by standard medical scoring tools (confirm with trial site).
  • People with a chronic hepatitis B (HBV) infection who have a very low level of the virus in their blood at screening, and who are already on antiviral medication following standard care guidelines.
  • People who are expected to live for at least 12 weeks.
  • People whose blood cell counts, liver enzyme levels, and kidney function all meet specific minimum requirements set by the trial (confirm with trial site for exact values).
  • Female patients who could become pregnant and who have a negative pregnancy test within 7 days before starting the trial.
  • People who are willing and able to follow all trial requirements, including attending scheduled appointments, following contraception guidelines, and completing follow-up visits.

Who may not be able to join:

  • People who are on a waiting list for a liver transplant, or who have severe liver disease.
  • People with a history of heart disease, or who have had a significant episode of gastrointestinal (gut) bleeding within the 4 weeks before starting the trial.
  • People who have had a blood clot or blockage event — such as a stroke, mini-stroke (TIA), 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 previously received any systemic cancer treatment, hormone-based cancer therapy, or immunotherapy.
  • People who have previously received a treatment called HAIC (hepatic arterial infusion chemotherapy).
  • People who have or have had a second type of cancer, with the exception of certain treated skin cancers or early-stage cervical cancer.
  • People with a weakened immune system, including those who are 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 the previous trial medication (confirm with trial site).
  • People who have previously received treatment within this same study.
  • People with certain other medical conditions or health issues that, in the treating doctor's judgement, could interfere with the trial, including: a history of lung disease affecting the air sacs; having both hepatitis B and hepatitis C infections at the same time; known pancreatitis; active tuberculosis; any active infection requiring treatment; a history of organ or tissue transplant; a diagnosed immune deficiency or use of immune-suppressing medications within 7 days before starting; an active autoimmune disease requiring treatment in the past 3 months, or a history of severe autoimmune disease (some specific conditions are excepted — confirm with trial site); having received a live vaccine within 30 days before starting; or a history of cancer that has spread to the brain or central nervous system (some exceptions apply for people who have completed treatment and are stable — confirm with trial site).
  • People taking medications known to interfere with the drugs used in this trial.
  • People receiving any other active cancer treatment not specified by this trial's protocol.
  • People who have received any other experimental treatment within 28 days of joining the study.
  • People who have previously been treated with certain immune checkpoint or T-cell targeting therapies, including specific types of antibody treatments (confirm with trial site for the full list).
  • People who are pregnant, breastfeeding, or people of reproductive potential who are not using an effective method of contraception as defined by the trial (acceptable methods include implants, injectable contraceptives, combined oral contraceptives, hormonal intrauterine devices, sexual abstinence, or a partner's vasectomy). Female patients of childbearing potential must also have a negative pregnancy blood test at screening.
  • People with a significant history of not following medical instructions, or who are unable to provide 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 23 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: 86-21-64041990

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
15 August 2025
Est. completion
1 August 2027

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Objective Response Rate (ORR) evaluated by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1

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: 23 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