Early Phase 1 Liver Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• The patient or their legal guardian must be willing to sign a consent form agreeing to take part.
• Adults aged over 18 and up to 70 years old, of any gender, may be considered.
• People with advanced solid tumours confirmed by laboratory testing of tissue or cell samples, who have already received at least one round of treatment, may be considered — this includes specific cancer types described below.
• People with cervical cancer (squamous cell, adenosquamous, or adenocarcinoma type) that has come back, spread, or kept growing after initial treatment, and where curative surgery or radiotherapy is no longer an option, who have had between 1 and 3 prior systemic treatments (such as chemotherapy), may be considered.
• People with Stage IV cervical cancer according to the FIGO 2018 classification system may be considered (confirm with trial site regarding staging flexibility).
• People with locally advanced or metastatic liver cancers — including hepatocellular carcinoma (liver cancer), intrahepatic cholangiocarcinoma (bile duct cancer starting in the liver), or cancer that has spread to the liver from elsewhere — who have met specific prior treatment requirements depending on cancer type, may be considered (confirm with trial site for details specific to each liver cancer type).
• People with liver cancer whose liver function scores at or below a certain level (Child-Pugh score of 7 or less) may be considered.
• People with other advanced solid tumours that have progressed after standard treatments or where no standard treatment is available — including but not limited to triple-negative breast cancer, non-small cell lung cancer (excluding certain subtypes), ovarian cancer, head and neck cancer, and colorectal cancer — may be considered.
• People who have a tumour large enough to be surgically removed or sampled by biopsy to produce the specialised immune cells used in this trial may be considered (specific size requirements apply; confirm with trial site).
• People with a life expectancy of at least 3 months may be considered.
• People who, after tumour removal or biopsy, still have at least one other measurable tumour that can be monitored during the trial may be considered.
• People with a good general performance level (rated 0 or 1 on a standard medical scale) may be considered; people with stable brain metastases require additional assessment by the trial doctor.
• People whose blood counts, kidney function, liver function, lung function, and heart function all meet the specific minimum levels set by the trial may be considered (confirm exact values with trial site).
• People who have recovered from side effects of previous cancer treatments to a mild or resolved level before starting the trial treatment may be considered.
• People who previously had serious bowel side effects from immune checkpoint therapy must have had no symptoms for at least 6 months and a normal colonoscopy result before being considered (this does not apply to colorectal cancer patients).
• People with hormone-related side effects from previous immunotherapy (such as an underactive thyroid) that have been stable for at least 6 weeks and are managed with non-steroid hormone replacement may be considered.
• People who agree to use highly effective contraception from the time of signing consent until at least 1 year after receiving the trial treatment may be considered.

Who may not be able to join:

• People whose cancer has only spread to the bones, with no other sites of disease.
• People with active cancer spread to the brain or central nervous system (stable brain metastases not requiring medication for at least 3 months may be assessed separately).
• People who have used Chinese herbal medicines or plant-based medicines with anti-cancer indications within 1 week before starting the preparatory chemotherapy phase of the trial.
• People who have been taking systemic steroid medicines (at or above a certain dose) or other immune-suppressing drugs within 2 weeks before starting the preparatory phase (inhaled, skin-applied, or hormone replacement steroids may be acceptable — confirm with trial site).
• People who have had major surgery within 4 weeks before enrolment, or who have major surgery planned during the trial (surgery specifically for preparing the trial's immune cells is excluded).
• People who have had another cancer in the past 3 years, or who currently have another cancer (some exceptions may apply for certain low-risk treated cancers — confirm with trial site).
• People with any primary immune system deficiency disorder, such as severe combined immunodeficiency or AIDS.
• People who have had an organ transplant at any time.
• People with active hepatitis B or hepatitis C infection meeting specific laboratory thresholds.
• People who test positive for HIV or syphilis antibodies.
• People with an uncontrolled, life-threatening bacterial, viral, or fungal infection at the time of treatment.
• People who have received a live or weakened (attenuated) vaccine within 4 weeks before starting the preparatory phase of the trial.
• People who have had unstable chest pain (angina) or a heart attack within the past 6 months, or uncontrolled blood clots, serious bleeding, or deep vein thrombosis within the past 12 months.
• People with a history of neurological or psychiatric conditions, including epilepsy or dementia.
• People with a known serious allergy to any of the medicines used in the trial, including cyclophosphamide, fludarabine, IL-2, or gentamicin (confirm full list with trial site).
• People assessed by the trial doctor as having a high risk of serious bleeding, including those whose tumours surround or have grown into major blood vessels, or who have had bleeding episodes within the past 60 days.
• People who have taken part in another clinical trial and received an investigational treatment within 30 days before signing the consent form.
• People whom the trial doctor considers unsuitable for any other reason, including those who had severe (Grade 3 or higher) side effects from previous immunotherapy.

Important: Always verify eligibility with the trial site directly before applying.