Phase 2 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:

As a blood donor (providing blood for the treatment):

• People who are able to understand and sign the consent forms, knowing this is an experimental study
• People aged 20 years or older
• People who have been diagnosed with liver cancer (hepatocellular carcinoma, or HCC) at an early to intermediate stage (Stage I, II, or IIIa), confirmed by tissue sample or medical imaging
• People who are scheduled to have, or have already had, their liver tumour fully removed through surgery or a targeted destruction procedure such as ablation or ethanol injection
• People whose blood test results, kidney function, and liver function fall within the required ranges as determined by the trial site
• Women who could become pregnant must confirm they are not pregnant at the screening stage and throughout the study

As a treatment recipient (receiving the experimental therapy):

• People who are able to understand and sign the consent forms, knowing this is an experimental study
• People who have had their liver cancer (HCC, Stage I, II, or IIIa) confirmed by a tissue or cell sample, and whose tumour has been completely removed within 12 weeks of signing consent, with removal confirmed by CT or MRI scan within 4 weeks of the first dose
• People whose liver is functioning at a level classified as Child-Pugh class A (a measure of liver health — confirm with trial site)
• People who are generally able to carry out daily activities with no more than mild limitations, based on a standard medical performance scale (ECOG score of 0 or 1)
• People whose life expectancy is at least 3 months or more
• People whose blood test results, kidney function, and liver function fall within the required ranges as determined by the trial site
• Women who could become pregnant must confirm they are not pregnant and are not breastfeeding at screening and throughout the study
• People who are willing to follow all study requirements and instructions
• All people who could father or become pregnant must be willing to use an approved, reliable method of contraception during the study and for at least 24 weeks after treatment ends. Accepted methods include: complete abstinence (if this reflects the person's usual lifestyle), surgical sterilisation (female or male), or a combination of two reliable contraceptive methods such as hormonal contraception, an intrauterine device, or barrier methods such as condoms or diaphragms. Periodic abstinence and withdrawal are not accepted

Who may not be able to join:

As a blood donor:

• People who have certain serious infectious diseases, including syphilis, HIV, HTLV, or conditions linked to a rare brain-wasting disease (such as Creutzfeldt-Jakob disease)
• People with ongoing active hepatitis, including active hepatitis B or C infection, alcohol-related hepatitis, or autoimmune hepatitis
• People with significant, unstable health conditions affecting the digestive system, kidneys, hormone glands, lungs, or heart, as assessed by the study doctor
• People who have had another type of cancer in the past 5 years, other than certain low-risk skin cancers, early-stage cervical cancer, or early-stage bladder tumours that were fully treated
• People with a history of immune deficiency or an autoimmune condition such as rheumatoid arthritis, multiple sclerosis, or Type 1 diabetes
• People who have received steroid medications affecting the whole body within 4 weeks before blood collection
• People who have received immune-suppressing treatment within 4 weeks before blood collection
• People who have received other cancer treatments within 3 months before blood collection
• People who have received a live (attenuated) vaccine within 4 weeks before blood collection
• People who have taken part in another experimental study and received an experimental treatment within 4 weeks before blood collection
• People with a known or suspected allergy to any ingredient in the study product, such as certain antibiotics (kanamycin, streptomycin) or albumin

As a treatment recipient:

• People with significant, unstable health conditions affecting the digestive system, kidneys, hormone glands, lungs, or heart, as assessed by the study doctor
• People with ongoing active hepatitis, including active hepatitis B or C infection, alcohol-related hepatitis, or autoimmune hepatitis
• People with a known or suspected allergy to any ingredient in the study product, such as certain antibiotics (kanamycin, streptomycin) or albumin
• People who have received steroid medications affecting the whole body within 4 weeks before treatment, or who plan to do so during the study
• People who have received immune-suppressing treatment within 4 weeks before treatment, or who plan to do so during the study
• People who have received other cancer treatments within 4 weeks before the study treatment (other than the curative removal procedure), or who plan to do so during the study
• People who have received a live (attenuated) vaccine within 4 weeks before treatment, or who plan to do so during the study
• People whose blood sample was not able to produce enough of the experimental treatment
• People who are unable to have an MRI or CT scan
• People with serious mental, social, or psychological difficulties that the study doctor believes could affect their ability to take part safely and reliably
• People who have taken part in another experimental study and received an experimental treatment within 4 weeks before the study dose

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