Clinical Study on the Efficacy of Autologous Cell Factor Induced Killer Cells in the Treatment of Colorectal Cancer

Laborértékek

• Had participated in other clinical trialists of drugs within 4 weeks before the start of the study;
  • Those who had hypertension that was inadequately controlled with a single antihypertensive agent (systolic blood pressure > 140 mmHg and diastolic blood pressure > 90 mmHg, as judged by the investigator), had myocardial ischemia or myocardial infarction of grade I or higher, arrhythmia of grade I and higher (including QT interval ≥ 440 MS), or cardiac dysfunction;
  • Those with a history of substance abuse who are unable to abstain or who have a history of mental disorders;
  • Presence of fungal, bacterial, viral, or other infections that are not controllable or require antibiotic therapy;
  • For subjects with prior chemotherapy use, ≥ grade 2 hematologic toxicity, or ≥ grade 3 nonhematologic toxicity according to nci-ctcae 5.0 criteria at enrollment; ⑥ Known presence of a history of HIV, or hepatitis B (HBsAg positive) or hepatitis C virus (anti HCV positive) nucleic acid test positive;
  • Presence of any indwelling catheter or drain (eg, biliary drain or pleural / peritoneal / pericardial catheter). Use of a dedicated central venous catheter was permitted (colostomy for patients with bowel cancer, percutaneous nephrostomy tube, indwelling Frey catheter, considered by the investigator for implications); ⑧ Presence of brain metastases, presence of a history or disease of the CNS such as seizure disorders, cerebral ischemia / hemorrhage, dementia, cerebellar disease, or any autoimmune disease involving the CNS;

• Age range 18-70 years;
  • Patients diagnosed with colorectal cancer, TNM stage III-IV;
  • Had at least one extracranially measurable lesion by recist1.1 criteria; ④ Patients who had failed at least one or two prior lines of standard therapy or relapsed, or who were intolerant to or voluntarily abandoned one or two prior lines of standard therapy; ⑤ Expected survival ≥ 90 days;
  • The major organs function normally; ⑦ The subject voluntarily joined this study, signed the informed consent, complied well and cooperated with the follow-up.