Hepatocellular Carcinoma
Conditions
Interventions
Cohort 1:The pathological and imaging assessment indicated that the patient was diagnosed with hepatocellular carcinoma. The first-line standard treatment failed: The subject received radiotherapy at
continued to receive targeted therapy (the same drugs as the first-line treatment) every day
received immunotherapy on the 5th day (the same drugs as the first-line treatment) and intravenous infusion of memory-like NK cells
received intravenous infusion of memory-like NK cells again on the 12th day
21 days constituted one treatment cycle. After two cycles of cell infusion, the efficacy was evaluated, and then continued targeted combined immunotherapy for maintenance treatment, and entered the fo
Cohort 2:The patient was diagnosed with liver cell carcinoma with lung metastasis and had not received any treatment: On the 1st and 3rd days of the treatment, radiotherapy was administered to the les
The targeted therapy (the same as the standard first-line treatment) was continued every day
On the 5th day, immunotherapy (the same as the standard first-line treatment) and intravenous infusion of memory-like NK cells were received
On the 12th day, memory-like NK cells were again intravenously infused
21 days constituted one treatment cycle. After two cycles of cell infusion, the efficacy was evaluated, and then targeted combined immunotherapy was continued for maintenance treatment, and the follow
Sponsors
Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. The subjects were able to understand the informed consent form, voluntarily participated and signed the informed consent form. 2. Age >= 18 years old, ECOG score 0-1. 3. Patients with multiple and/or distant liver metastases of hepatocellular carcinoma who failed the first-line standard treatment (disease progression after treatment or intolerable treatment side effects) as recommended by the guidelines; or patients without any treatment, diagnosed as hepatocellular carcinoma lung metastasis by histological or cytological and/or impact assessment, with at least one measurable lesion for efficacy evaluation. 4. All subjects should provide tumor tissue samples that are archived or freshly obtained within 2 years before signing the informed consent form, preferably the newly obtained tumor tissue samples. 5. Blood, liver and kidney functions meet the following standards: (1) Neutrophil count >= 1.5 × 10^9/L (2) Platelet count >= 75 × 10^9/L; (3) Hemoglobin concentration >= 90 g/L; (4) Serum albumin concentration >= 30 g/L; (5) Bilirubin = 3 months. 9. Patients voluntarily joined this study, signed the informed consent form, and had good compliance.
Exclusion criteria
Exclusion criteria: 1. Within 2 weeks prior to the first administration, perform palliative local treatment for the lesion; within 2 weeks prior to the first administration, have received systemic non-specific immunomodulatory therapy (such as interleukins, interferons, thymosin, etc.); within 2 weeks prior to the first administration, have received traditional Chinese medicine or Chinese patent medicine with anti-tumor indications. 2. The subject has active bacterial or fungal infection (>= 2 grade of NCI-CTC, version 3). 3. The subject has HIV, HCV, HBV infection, uncontrolled coronary artery disease or asthma, uncontrolled cerebrovascular disease or other diseases that the investigator considers not eligible for inclusion. 4. The subject has autoimmune diseases or immunodeficiency, and is being treated with immunosuppressive drugs. 5. Pregnant or lactating women. Women of childbearing age must test negative for pregnancy within 7 days before enrollment. 6. Abusing drugs, with clinical or psychological or social factors affecting informed consent or study implementation. 7. Within 28 days before treatment, received live vaccine vaccination. 8. Subjects requiring long-term systemic hormone or any other immunosuppressive drug treatment, excluding inhaled hormone treatment. 9. Within 4 weeks before the first study treatment, received major surgical procedures (craniotomy, thoracotomy or laparotomy) or expected to need major surgery during the study treatment. 10. Subjects with symptomatic and requiring clinical intervention central nervous system metastasis. 11. Those who may be allergic to the study drug or any of its excipients. 12. Subjects with gastrointestinal bleeding or high risk of bleeding within 2 weeks before enrollment. 13. Subjects considered not eligible for inclusion by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose-limiting toxicity (DLT);The incidence rate of adverse events;physical examination;vital signs; | — |
Secondary
| Measure | Time frame |
|---|---|
| progression free survival;Objective Response Rate;overall survival;Disease control rate; | — |
Countries
China
Contacts
Public ContactBaorui Liu/Jie Shen
Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School
Outcome results
None listed