Status:
RECRUITING
Adoptive Autologous iNKT Cells for the Treatment of Progressed Hepatocellular Carcinoma Continuing on PD-1 Inhibitor Therapy
Lead Sponsor:
Beijing YouAn Hospital
Collaborating Sponsors:
Beijing Gene Key Life Technology Co., Ltd
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
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 q...
Detailed Description
Single center, randomized, open trial in Barcelona Clinic Liver Cancer（BCLC）C stage patients with progressed HCC after anti-angiogenic targeted drugs combined with PD-1 monoclonal antibody therapy to ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 26 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2025
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT05962450
Start Date
October 26 2023
End Date
August 1 2025
Last Update
January 16 2024
Active Locations (1)
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1
Beijing Youan Hospital,Capital Medical University
Beijing, Beijing Municipality, China, 100069