Clinical trial · Interventional
Adoptive Autologous iNKT Cells for the Treatment of Progressed Hepatocellular Carcinoma Continuing on PD-1 Inhibitor 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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this clinical trial is to explore the efficacy and safety of autologous iNKT cells in patients with progressed hepatocellular carcinoma (HCC) after treatment with PD-1 antibody. The main question it aims to answer are: * the efficacy of autologous iNKT cells in patients with progressed HCC after treatment with PD-1 antibody. * the safety of autologous iNKT cells in patients with progressed HCC after treatment with PD-1 antibody. Participants will be randomized 1:1 to receive Regorafenib + PD-1 + iNKT cells (RPI group) or the treatment of Regorafenib + PD-1 (RP group). Researchers will compare RPI group and RP group to see whether the iNKT cells can achieve a better therapeutic effect on HCC patients with PD-1 resistance.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| iNKT Cells | Biological | — | UNRESOLVED |
| PD-1 | Drug | — | UNRESOLVED |
| Regorafenib | Drug | Regorafenib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- RPI group
- description
- Regorafenib + PD-1 + iNKT cells
- interventionNames
- Biological: iNKT Cells
- Drug: PD-1
- Drug: Regorafenib
- type
- OTHER
- label
- RP group
- description
- Regorafenib + PD-1
- interventionNames
- Drug: PD-1
- Drug: Regorafenib
Primary outcomes (1)
- measure
- Progression-Free Survival (PFS)
- timeFrame
- The time from enrollment to disease progression, or death from any cause, whichever occurred first, up to 24 months.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available