Using iNKT cells to treat advanced liver cancer after PD-1 therapy
An Open Label, Randomized, Controlled, Clinical Trial of Adoptive Autologous Invariant Natural Killer T Cells for the Treatment of Progressed Hepatocellular Carcinoma Continuing on PD-1 Inhibitor Therapy
PHASE2 · Beijing YouAn Hospital · NCT05962450
This study is testing if adding a special type of immune cell treatment to standard drugs can help people with advanced liver cancer who haven't responded well to other therapies.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 84 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Beijing YouAn Hospital (other) |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Beijing, Beijing) |
| Trial ID | NCT05962450 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the safety and efficacy of autologous iNKT cells in patients with progressed hepatocellular carcinoma (HCC) who have previously undergone treatment with PD-1 inhibitors. Participants will be randomly assigned to receive either a combination of Regorafenib, PD-1, and iNKT cells or just Regorafenib and PD-1. The study will assess the therapeutic effects of the iNKT cells compared to the standard treatment. The trial includes a screening period, treatment period, and follow-up to monitor patient outcomes and safety.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with progressed hepatocellular carcinoma after PD-1 therapy and a life expectancy of at least 12 weeks.
Not a fit: Patients with severe hypertension, cardiac disease, or uncontrolled infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a new treatment option for patients with advanced liver cancer who have not responded to existing therapies.
How similar studies have performed: While the use of iNKT cells in cancer treatment is an emerging field, this specific approach has not been widely tested, making it a novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18-75 years of age. * Barcelona Clinic Liver Cancer（BCLC） C stage hepatocellular carcinoma (HCC) confirmed by CT, MRI, and/or histopathology. * Progressed after receiving anti-angiogenic targeted drugs combined with PD-1 monoclonal antibody. * Life expectancy of at least 12 weeks. * Child-Pugh A/B. * Voluntary signing of informed consent. Exclusion Criteria: * History of severe hypertension or cardiac disease. * known central nervous system (CNS) tumor or combined with other malignant disorders. * Uncontrolled immune system or infectious disease. * Known history of the human immunodeficiency virus (HIV) or syphilis infection. * History of stem cell transplant or organ allograft. * History of allergy to immunotherapy or related drugs. * Bilirubin is twice times the upper limit of normal. * Glomerular filtration rate （GFR）\< 60ml/min. * Serious complications include moderate or severe infective pleural and peritoneal effusion, pericardial effusion, upper gastrointestinal bleeding, hepatic encephalopathy. * Pregnancy or lactation. * History of severe allergy to any monoclonal antibody or anti-angiogenic targeted drug. * Deemed not suitable for cellular immunotherapy by the investigators.
Where this trial is running
Beijing, Beijing
- Beijing Youan Hospital,Capital Medical University — Beijing, Beijing, China (RECRUITING)
Study contacts
- Principal investigator: Jun Lu, MD. — Beijing YouAn Hospital
- Study coordinator: Jun Lu, MD.
- Email: lujun98@ccmu.edu.cn
- Phone: 86-13661381489
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hepatocellular Carcinoma