Hepatocellular carcinoma
Conditions
Interventions
High dose group: 10^10 TIL
Low dose group: 10^9 TIL
Sponsors
The Third Affiliated Hospital of The Second Military Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged = 18 years, gender unlimited; 2. Patients diagnosis of primary hepatocellular carcinoma by histopathology and/or cytology; 3. At the initial enrollment evaluation, patients were expected to accept radical resection of liver cancer and meet at least one of the following high-risk recurrence factors after surgery: (1)There are 3 or more tumor lesions in the liver; (2)The diameter of a single tumor lesion is >8cm; (3)Existence macrovascular tumor thrombus; (4)>5 MVI or MVI occurred in the distant paracancer tissues; 4. Before enrollment (after radical resection of liver cancer), imaging evaluation was performed to ensure that the tumor was completely removed (clear margin); 5. Must have at least 1 resectable lesion (diameter =2 cm); 6. ECOG score = 3.0x10^9/ L, neutrophil count >=1.5x10^9/ L, platelet countPlatelet count =8.0E10/ L, hemoglobin =80g/L (2) Liver function: aspartate aminotransferase (AST)=5 times normal value, alanine aminotransferase (ALT)=5 times normal value, bilirubin = 28 g/L; (3) Renal function: creatinine (Cr)= 50 mL/min; 9. An estimated life expectancy of >= 3 months; 10. Participation in this clinical study voluntary, can cooperate with researchers to carry out research, and sign informed consent.
Exclusion criteria
Exclusion criteria: 1. Primary hepatocellular carcinoma (HCC) has recurred in the past, or has other types of liver cancer at the same time (such as intrahepatic cholangiocarcinoma, mixed type of liver cancer); 2. Have a history of high fever or severe infection within 2 weeks prior to pretreatment, or are expected to undergo systemic anti-infective therapy or systemic steroid therapy during this trial; 3. Hepatic encephalopathy occurred within 2 weeks before pretreatment; 4. Previous or screening with autoimmune liver disease; 5. Screening with moderate or higher peritoneal effusion; 6. Clear neurological/psychiatric symptoms are known to be associated with brain metastases and/or assessed by MMSE; 7. Anti-tumor therapy such as chemotherapeutic drugs, targeted drugs, radio frequency ablation or minimally invasive intervention was received within 4 weeks before pretreatment; 8. Have received or are expected to participate in this study within 4 weeks before pretreatment to receive TIL required focus radiotherapy, or tumor evaluation focus (target focus or non-target focus) radiotherapy, or radical radiotherapy; 9. Any toxic response resulting from previous anti-tumor treatment prior to pretreatment did not return to grade 1 or below (CTCAE5.0 version); 10. Previous history of organ / stem cell transplantation or expected to be involved in this trial for organ / stem cell transplantation; 11. Left ventricular ejection fraction (LVEF)<45% or New York Heart Association (NYHA)= grade 2; 12. Known or private HIV infection or syphilis infection; 13. The previous 3 years other system primary malignant tumor history (except skin basal cell carcinoma or cervical carcinoma in situ); 14. A known allergy to two or more non-homogeneous foods/drugs, or a known history of allergies to pre-treated drugs, including cyclophosphamide, fludarbin, interleukin; 15. Pregnant, lactating women or within one year of having a family plan; 16. Participated in other clinical trials within 3 months prior to screening; 17. Other circumstances that the researchers considered inappropriate to participate in the experiment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| DLT; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-Free Survival;Overall Survival;EQ-5D score;EORTC QLQ-C30 and EORTC QLQ-HCC18 score; | — |
Countries
China
Contacts
Public ContactZhengang Yuan
The Third Affiliated Hospital of The Second Military Medical University
Outcome results
None listed