ACTL-targeted anti-tumor cell immunotherapy combined with TKI in the treatment of advanced EGFR-sensitive mutation-positive non-small cell lung cancer: a randomized open, parallel controlled, multicen

Date:2016-09-21 Author:益世康宁 Source:益世康宁

Clinical trial contact number:

68217221/68136714/68136396/68136043/68217102

standard constrain

1. The subject or legal guardian can understand and sign the informed consent form;
2. Age from 18 to 70 years old; no gender limit
3. Advanced or recurrent non-small cell lung adenocarcinoma with positive EGFR sensitive mutations (including EGFR exon 19 deletion or exon 21 L858R substitution mutation) (except for brain metastases); oral EGFR-TKI treatment for 3 months without Progressing patients;
4. The tumor tissue HLA-I antigen is positive;
5. At least one of the tumor-associated antigens related to peripheral blood or histopathological examination is positive, including: carcinoembryonic antigen (CEA), keratin (CK19; cyfra21-1), Her-2/neu, MAGE-A3 antigen, Survivin antigen (survivin), MUC-1 antigen and prostate specific membrane antigen (PSMA) ≥ 1 items are positive;
6. Peripheral blood white blood cells (WBC) ≥3.0×109/L; peripheral blood hemoglobin (Hb) ≥80g/L; peripheral red blood cells (RBC) ≥3.0×1012/L; peripheral blood platelets ≥1×1011/L
7. No serious autoimmune disease or immunodeficiency disease; immune function is basically normal;
8. No infectious diseases (syphilis, AIDS); hepatitis B, hepatitis C inactive period;
9. ECOG score ≥ 2 points;
10. Tumor assessment has 1 or more measurable lesions;

Exclusion criteria

1. Allergic constitution; allergic to biological products;
2. Patients who cannot complete the treatment due to various reasons or the researcher's judgment;
3. Patients with severe primary diseases of cardiovascular, liver and kidney, liver function (ALT, AST, GGT) exceeding the upper limit of normal value by 1.5 times; BUN or Cr exceeding the range of normal value (those with clinical significance determined by the doctor);
4. Suspected or true history of alcohol or drug abuse, or other conditions that reduce the possibility of enrollment or complicate enrollment according to the judgment of the investigator, such as frequent changes in the working environment, which may easily cause loss to follow-up.
5. ACTL treatment has poor compliance and cannot complete ACTL treatment.
6. Merge other malignant tumors;
7. People with mental illness and mental or language impairment;
8. Pregnancy (women of childbearing age with a positive pregnancy test) or breastfeeding women;
9. Subjects of childbearing age cannot take effective contraceptive measures;


Information source: Official website of Jiangsu Provincial People's Hospital

Information address: http://www.jsph.org.cn/huanzhetongdao/keshijianjie/neike/zhongliuke/yaopinyanjiu/2016-09-21/17737.html

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