Hepatocellular carcinoma
Conditions
Interventions
Sponsors
The Central Hospital of Lishui City
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Patients willing to participate in the study can understand and sign informed consent; 2. Immunohistochemistry was used to detect the tumor tissue and it was confirmed as primary HCC; 3. The expression of GPC3 was more than 25% in HCC by immunohistochemistry; 4. Aged between 18-70 years; 5. Standard treatment (including but not limited to standard treatment of sorafenib, oxaliplatin, hepatic artery perfusion, etc.) for failed HCC; It has recovered from the previous treatment, including all treatment side effects (except hair loss) have been reduced to less than level 1 (according to CTCAE version 5.0); 6. The expected survival time is not less than 12 weeks; 7. At least one measurable lesion (>=10 mm); 8. Liver function was child Pugh a or B, renal function was normal; 9. ECoG physical status score is 0-1, or KPS functional status score is greater than 70; 10. The blood routine test reached the following indicators: WBCs (white blood cell count) >=2.5x10^9/L; PLT (platelet count) >=60x10^9/L; HB (hemoglobin) >=90 g/L; lymphocyte proportion >=15%, lymphocyte count >=500/UL or CD3 positive T cell number >=150/UL; ANC (neutrophil absolute number) >=1.5x10^9/L; no G-CSF, TPO, EPO treatment within 2 weeks; 2 weeks No blood transfusion was received; 11. Be able to collect blood from normal vein and single machine, and be able to carry out lymphocyte clearance treatment.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating female patients; 2. The patient has brain metastasis; 3. Patients with hepatic encephalopathy in the past or at present; 4. Patients with active infectious diseases (including HIV antibody positive, Treponema pallidum specific antibody positive, active tuberculosis, etc.); 5. Patients with previous history of central nervous system diseases; 6. Patients who received interferon treatment within 3 months; 7. Patients who have been treated with systemic steroids for a long time or have autoimmune diseases; 8. Patients who had used immunosuppressive drugs such as cyclophosphamide within 4 weeks before receiving peripheral cell collection; 9. Patients who are still in the clinical observation period of other drugs within one month before receiving peripheral cell collection; 10. Patients who have not recovered from the acute side effects of previous treatment; 11. Patients who received radiotherapy within 4 weeks before receiving peripheral cell collection; 12. Patients who have received any gene therapy products in the past; 13. Patients who have received cancer immunotherapy within 3 months (CIK, DC, DC-CIK, LAK, NK, TIL, CTL, tcr-t, car-t, PD-1 antibody, PDL-1 antibody, etc.); 14. The positive rate of car in T cell culture for 7 days was lower than 20%; 15. The cell expansion rate was less than 3 times; 16. Patients allergic to gentamicin and penicillin; 17. Patients with allergic history to cyclophosphamide, fludarabine, etc; 18. Patients who are allergic to immunotherapy and related drugs (including ADI, IL-6 antibody, glucocorticoid, etc.); 19. Have a heart disease that has not been effectively controlled and needs treatment; 20. Patients with poor blood pressure control (>=Level 2) after drug treatment; 21. Patients with active gastrointestinal bleeding (more than 2 + patients in fecal occult blood test); 22. Patients who have received or are ready to receive organ transplantation; 23. Patients with hyponatremia (blood sodium 300mg/D; clopidogrel >75mg/D); 27. Patients with organ failure or dysfunction: Cardiac function: cardiac function grade 3 or above (according to NYHA standard of New York Heart Association) Pulmonary function: respiratory failure; Brain function: central nervous system abnormality or disturbance of consciousness; 28. Patients with any serious and uncontrollable diseases (including but not limited to: unstable angina, congestive heart failure, grade III or IV heart disease, serious arrhythmia, serious metabolic diseases, etc.); 29. Patients who have a history of acute drug allergy, especially those who are allergic to immunoglobulins; 30. Patients with other tumor history within 5 years (except those who have been completely cured and do not need follow-up treatment); 31. Patients who are participating in other clinical trials; 32. The researchers think it is not suitable for patients participating in the clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AFP; | — |
Countries
China
Contacts
Public ContactJi Jiansong
Intervention Department of Lishui Central Hospital
Outcome results
None listed