Hepatocellular carcinoma
Conditions
Interventions
TIL:injection of TILs
TACE:TACE therapy
Sponsors
Shanghai Sixth People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged from 18 to 70 years, no gender limitation; 2. Histopathological diagnosis of advanced hepatocellular carcinoma; 3. There is at least one measurable lesion according to RECIST 1.1 standards, and the diameter of a single tumor is >= 8 cm, or the maximum diameter of multiple lesions is >= 5 cm, according to CT or MRI cross-sectional images; 4. ECOG score =3x10^9/L, lymphocyte count >= 0.5x10^9/L, neutrophil count >=1.5x10^9/L, platelet count >= 80x10^9/L, hemoglobin >=100 g/L; (2) Liver function: AST = 28 g/L; (3) Renal function: Creatinine (Cr)=50 mL/min; 7. Estimated survival >= 6 months; 8. Patients with reproductive potential must be willing to take appropriate precautions to avoid pregnancy during the study period and to use an approved, highly effective contraceptive method during treatment and for 12 months after finally receiving the agreed relevant treatment; 9. Participate in the clinical study voluntarily, cooperate with the investigator to carry out the study, and sign informed consent.
Exclusion criteria
Exclusion criteria: 1. Have a history of high fever or severe infection 2 weeks prior to preconditioning, or are expected to receive systemic anti-infective therapy or systemic steroid therapy during study participation; 2. Hepatic encephalopathy occurred within 2 weeks before pretreatment; 3. Patients with autoimmune liver disease before or during screening; 4. During screening, there was more than medium amount of peritoneal effusion; 5. Known to have brain metastases and/or obvious neurological/psychiatric symptoms assessed by MMSE; 6. Received anti-tumor therapy such as chemotherapy drugs, targeted drugs, radiofrequency ablation, minimally invasive intervention or surgery within 4 weeks prior to pretreatment; 7. Have received or are expected to receive radiotherapy for TIL, tumor evaluation (target or non-target), or radical radiotherapy within 4 weeks prior to pretreatment; 8. Any toxicity resulting from prior antitumor therapy before pretreatment did not return to grade 1 or below (CTCAE version 5.0); 9. Prior exposure to PD-1 antibodies, or PD-L1 antibodies, or any immunotherapy/vaccine; 10. Have a history of organ/stem cell transplantation or are expected to need organ/stem cell transplantation during the study period; 11. Left ventricular ejection fraction (LVEF) = 2; Known or self-reported HIV infection; 13. A history of other systemic primary malignant tumors within 3 years (except basal cell carcinoma of the skin or carcinoma in situ of the cervix); 14. Known to be allergic to 2 or more non-similar foods/drugs, or known to be allergic to pre-treated drugs (including cyclophosphamide, fludarabine, interleukin); 15. Women who are pregnant or breast-feeding or have a birth plan within the past 1 year; 16. Participated in other clinical trials within 3 months prior to screening; 17. Other circumstances that the investigator considers inappropriate for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tumor marker levels;IFN-?, CRP, TNFa;Quality of Life, QOL; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-Free Survival (PFS);Overall survial;Duration of remission (DOR); | — |
Countries
China
Contacts
Public ContactZhou Yuan
Shanghai Sixth People's Hospital
Outcome results
None listed