Clinical Study of MAK Immune Cells in the Treatment of PHC

Study Overview
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Brief Summary
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The investigators will plan to recruit 20 patients with liver cancer CNLC stage Ⅲa and Ⅲb who are older than 18 years old. Peripheral blood mononuclear cells were obtained and then the MAK(Mixed-activated Killer) cells were injected, and then the safety and efficacy were observed.

Detailed Description
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The investigators will plan to recruit 20 patients with liver cancer CNLC stage Ⅲa and Ⅲb who are older than 18 years old. Peripheral venous blood was collected twice (50-60ml/time, 2 times, 1 week apart) from each patient. Peripheral blood mononuclear cells were separated, induced, expanded, and cultured in vitro for a total of 1 week to obtain physiological conditions Immune cell populations with tumor-killing activity (mainly MAK immune cells mainly CD3-CD16 + CD56 + and CD3 + CD56 +), and then the MAK(Mixed-activated Killer) cells were injected intravenously for three days. Observe that the patient received cell therapy 24h, The safety and efficacy of 1 month, 2 months, and 3 months, and monitoring of adverse reactions.

Official Title
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Clinical Study on the Safety and Efficacy of Mixed-activated Killer Immune Cells in the Treatment of Primary Hepatocellular Carcinoma

Conditions
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Primary Hepatocellular Carcinoma

Intervention / Treatment
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* Other: Mixed-activated Killer Immune Cells


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age over 18 years old, regardless of gender. Patients with primary hepatocellular carcinoma. According to the Regulations for Diagnosis and Treatment of Primary Liver Cancer (2019 Edition) by the Health Commission of the People's Republic of China Liver cancer staging scheme, patients with Ⅲa and Ⅲb. The expected survival time is ≥6 months. Peripheral blood white blood cell count ≥3×10^9 /L. Understand and voluntarily sign the informed consent form. Exclusion Criteria: Patients with immunodeficiency or autoimmune diseases (such as rheumatoid arthritis, systemic lupus erythematosus, multiple Primary sclerosis, insulin dependent diabetes, etc.). Patients with a history of other malignant tumors in the past 5 years. Patients who participated in other clinical trials or clinical research treatments within 3 months before this clinical study By. Patients who have received other cell therapy within the past 6 months. Patients with fever who have not effectively controlled the infection. Patients with high allergies or a history of severe allergies. Patients who are allergic to albumin. Patients after organ transplantation; patients who have been using or are using immunosuppressive agents for a long time.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: To evaluate the safety and reliminary efficacy of MAK immune cells in the treatment of PHC.<br>To evaluate the safety and reliminary efficacy of MAK immune cells in the treatment of primary hepatocellular carcinoma. | Other: Mixed-activated Killer Immune Cells<br>* Mixed-activated Killer Immune Cells Peripheral intravenous infusion therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detecting the dynamic changes of circulating tumor cell count ( > 4 CTC counts per milliliter of blood acted as positive ) | Peripheral blood was collected 6 times at baseline, 24 hours after two MAK cell transfusions, and 1, 2, and 3 months after the last MAK cell transfusions to detect the changes in the number of circulating tumor cells ( > 4 CTC counts per milliliter of blood acted as positive ). | three months | 
| The size (tumor diameter) and number (tumor recurrence lesions) of PHC tumors were examined by enhanced abdominal CT | At baseline and 1, 2 and 3 months after the last cell transfusion, a total of 4 abdominal enhanced CT examinations were performed to count the tumor size (tumor diameter) and number of tumor recurrence lesions. | three months |