a clinical study in patients with high-risk recurrent primary hepatocellular carcinoma using autologous tils

Conditions: Hepatic Carcinoma

Summary: early clinical trials on evaluating the tolerance, safety and efficacy of autologous tils in high-risk recurrent primary hepatocellular carcinoma


Eligibility criteria:
inclusion criteria: 1. age ≥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: ①there are 3 or more tumor lesions in the liver; ②the diameter of a single tumor lesion is \>8cm; ③existence 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 \<2; 7. child-pugh score ≤7; 8. hematology and organ function indicators should be met simultaneously: (1) white blood cell count ≥3.0e+9/ l, neutrophil count ≥1.5e+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 ≤5 times normal value, serum albumin ≥28 g/l; (3) renal function: creatinine (cr)≤1.5 times normal limit, creatinine clearance ≥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: 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.

Keywords: til; hcc; clinical research