Early Phase 1 Liver Cancer Trial, Recruiting NCT06418659 Sponsor: Shanghai Changzheng Hospital Condition: Liver Cancer
Back to Liver Cancer

Early Phase 1 Liver Cancer Trial, Recruiting

NCT06418659
Recruiting Early Phase 1

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:

  • Adults aged 18 years or older, of any gender
  • People who have a confirmed diagnosis of hepatocellular carcinoma (liver cancer), confirmed using recognised medical guidelines
  • People whose liver cancer cannot be removed by surgery
  • People whose liver cancer has gotten worse after at least one standard treatment, or who were not suitable for standard treatments, or who are unlikely to benefit from them
  • People who have at least one measurable area of cancer that can be tracked using a specific imaging method (called mRECIST)
  • People with a life expectancy of at least 12 weeks
  • People whose general physical functioning falls within a certain range on a standard medical scale (called ECOG Performance Status 0 to 2), meaning they are able to carry out at least some daily activities (confirm with trial site)
  • Men who are able to father children, and women who could become pregnant, who are willing to use a highly effective form of contraception throughout the trial and for 6 months after the trial treatment ends
  • Women of childbearing age who have had a negative blood pregnancy test within 7 days before starting the trial treatment
  • People who are willing to give written consent to participate and are able to follow the trial requirements

Who may not be able to join:

  • People whose liver is not working well enough, based on specific blood test results measuring liver proteins and enzymes (confirm with trial site for exact levels)
  • People whose kidneys are not working well enough, based on specific blood test results (confirm with trial site for exact levels)
  • People with low levels of certain blood cells (white blood cells, platelets, or red blood cells), below specific levels measured by blood tests (confirm with trial site)
  • People with a blood clotting measure (called INR) above a certain level, indicating a blood clotting problem
  • People who have previously had a liver transplant
  • People with poorly controlled high blood pressure, diabetes, or serious heart or lung conditions
  • People whose cancer has spread outside the liver and who have not yet tried a first-line (initial standard) systemic treatment, unless they were not suitable for such treatment — or people who are currently responding well to systemic treatment
  • People who have received certain cancer treatments (such as targeted therapy, immunotherapy, chemotherapy, or radiation) within a recent window of time before the trial starts (ranging from 2 to 4 weeks depending on the treatment type), unless the cancer continued to progress despite those treatments
  • People who are still experiencing side effects of grade 2 or higher from previous cancer treatments (except for hair loss or other effects judged manageable by the medical team)
  • People who have had serious liver-related complications — such as gastrointestinal bleeding, significant confusion caused by liver disease, or fluid build-up in the abdomen that is difficult to treat — within 2 weeks before starting the trial
  • People with an active, uncontrolled infection (such as a lung or abdominal infection)
  • People who have had another type of cancer within the past 5 years, with some exceptions for certain low-risk cancers that were treated successfully (confirm with trial site)
  • People with certain levels of hepatitis B or hepatitis C virus still active in their blood, above specific thresholds (confirm with trial site)
  • People who are HIV-positive
  • People who are allergic to MRI contrast dye (the substance used to enhance MRI scans)
  • Women who are pregnant, breastfeeding, or may be pregnant
  • People who have taken part in another clinical drug trial within 4 weeks before starting this trial
  • People who have any other medical condition that the trial doctor believes would make participation unsafe or 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 22 July 2026
Early Phase 1 studies are small, early exploratory studies that come before the main Phase 1 to 3 testing, so a standard phase success rate does not apply.

Contact this trial

Principal Investigator: Wei-Fen Xie, M.D., Shanghai Changzheng Hospital

Phone: +8613482705212

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
Early Phase 1
Sponsor
Shanghai Changzheng Hospital
Registry
ClinicalTrials.gov
Start date
12 October 2024
Est. completion
1 April 2026

Where this trial is recruiting

🇨🇳 China

Primary endpoints

(Escalation part) To evaluate the tolerability and safety for intravenous CD-801 in subjects with hepatocellular carcinoma (HCC); (Expansion part) To assess the objective response rate (ORR) by modified Response Evaluation Criteria in Solid Tumours (mRECIST).

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: 22 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