Hepatocellular Carcinoma
Conditions
Interventions
Sponsors
Independent Institute
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. men or women aged 18~70 years old with refractory Hepatocellular Carcinoma; 2. tumor tissues samples confirmed as GPC3-possitive; 3. have at least one new measurable tumor lesion compared with previous irradiated region; 4. expected survival=12 weeks; 5. ECOG scored as 0-1 or KPS grading>80; 6. adequate venous access for apheresis or venous blood collection, and no other contraindication of blood cell separation; 7. Blood examination: WBC = 2.5×10^9/L; PLT=60×10^9/L; Hb=9.0g/dL; MID =1.0×10^9/L; LY = 0.4×10^9/L; LY 8. Blood biochemistry: serum Alb = 30g/L; serum Lipase and Amylase< 1.5 ULN; serum creatinine=1.5UL; NALT and AST=2.5ULN; TBiL=2.5ULN; 9. PTINR<1.7; 10. patients with willingness to be in this study and able to provide informed consent; All laboratory test result shall be within the range of stability, and without continuous support treatmen.
Exclusion criteria
Exclusion criteria: 1. CAR-T positive rate<10% 2. pregnant women or women in lactation 3. HIV/AIDS infection; 4. active infection; 5.during ongoing treatment using systemic steroid or steroid inhalants; 6.Allergic to any immunotherapies or related drugs; 7.with hepatic encephalopathy past or currently; 8.with asctic fluid needed to treat; 9.patients in need of treatment for heart disease or for poor controlled hypertension; 10.subjects with unstable or active peptic ulcer or alimentary tract hemorrhage; 11.subjects with previous organ transplantation or ready for organ transplantation; 12.hyponatremia,serum Na<125mmol/L; 13.Baseline serum potassium<3.5mmol/L(Potassium supplement recovering to the criterion is not excluding) 14.Patients need to accept anticoagulant therapy(taking Warfarin and Heparin). 15.chemoradiotherapy,targeted therapy Or TACE ever used in previous 4 weeks; 16.the concomitant anti-tumor treatment. subjects judged by investigators as not appropriate for this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety and tolerance ;cell pharmacokinetics; | — |
Countries
China
Contacts
Public ContactBo Zhai
Renji Hospital, Shanghai Jiao University School of Medicine
Outcome results
None listed