UnknownPhase 1

Immunotherapy of Advanced Hepatitis B Related Hepatocellular Carcinoma With γδT Cells

China20 participantsStarted 2019-07-23

Plain-language summary

To evaluate the safety, tolerability and efficacy of autologous γδT cells in the treatment of advanced hepatitis B-related hepatocellular carcinoma.

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Patients should sign informed consent form voluntarily and comply with the requirements of this study.
. Gender unlimited, age 18 to 70 years old.
. Hepatocellular carcinoma histopathology proven by liver fresh biopsy.
. According to the 2018 edition of the EASL guidelines for primary liver cancer, patients were diagnosed with advanced HBV-related hepatocellular carcinoma (BCLC stage B and C) by pathology and imaging; all patients required antiviral therapy with nucleoside analogues; other treatments (e.g. interventional therapy) at least 2 weeks prior to γδT cell infusion; patients can take the first- or second-line targeted drugs recommended by the guidelines, such as lenvatinib or sorafenib.
. Liver function: Child-Pugh class A/B (5-9), Eastern Cooperative Oncology Group (ECOG) Performance status 0-2.
. Expected survival ≥ 6 months.
. Male and female of reproductive potential must agree to use birth control during the study and for at least 30 days post study.

Exclusion criteria

. Combine other viral liver diseases or other liver disease patients.
. Acute infection, gastrointestinal bleeding, etc. occurred within 30 days before screening.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of adverse events (AEs) and serious adverse events (SAEs)

Timeframe: 14 months

Overall survival (OS)

Timeframe: 14 months

Trial details

NCT IDNCT04032392

SponsorBeijing 302 Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-07-30

Contact for this trial

Yuanyuan Li, Dr

+86 01066933333 lyy020818@sina.com

View on ClinicalTrials.gov More Hepatocellular Carcinoma trials