Continuous recruitment of multi-center clinical studies of cell immunotherapy for newly diagnosed advanced lung cancer
Date：2017-09-08
Author：admin
Source：
Led by the People's Hospital of Jiangsu Province, approved by the Health and Family Planning Commission of Jiangsu Province, and jointly carried out by multiple hospitals, the country's first "ACTL targeted anti-tumor cell immunotherapy combined with TKI for the treatment of advanced EGFR-sensitive mutation-positive lung adenocarcinoma" was randomly opened , A blank-controlled multi-center phase II clinical study, and the current patient data is good. Now this project continues to recruit patients, I urge everyone to support us! Convenient, please help forward!
standard constrain:
1. Newly treated advanced or recurrent lung adenocarcinoma (except brain metastases)
a. EGFR sensitive mutation positive (EGFR exon 19 deletion or 21 exon L858R substitution mutation);
b. Oral EGFR-TKI Kaimei sodium for 3 months and no progress patients;
c. The tumor tissue HLA-I antigen is positive;
d. Have not received other treatment (except postoperative adjuvant chemotherapy);
e. At least one of the tumor-associated antigens related to histopathological examination is positive, including: carcinoembryonic antigen (CEA), keratin (CK19), Her-2/neu, MAGE-A3 antigen, survivin antigen (survivin), Prostate specific membrane antigen (PSMA), HLA-II ≥1 items are positive;
f. Tumor assessment has 1 or more measurable lesions;
2. Age 18～75 years old; no gender limit
3. ECOG score ≤ 2 points; able to go to the research hospital for monthly inspection and follow-up;
4. 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;
5. The subject or legal guardian can understand and sign the informed consent form;
6. No serious autoimmune disease or immunodeficiency disease; immune function is basically normal;
7. No infectious diseases (syphilis, AIDS); hepatitis B, hepatitis C inactive period;
Exclusion criteria:
1. Brain transfer;
2. Those who are allergic to biological products;
3. Patients with severe primary diseases of cardiovascular, liver and kidney, liver function (ALT, AST) exceeding the upper limit of normal 2.5 times; BUN or Cr exceeding the normal range (the doctor judges clinical significance); the liver metastasis exceeds 5 Times or more;
4. Merge other malignant tumors;
5. People with mental illness and mental or language impairment;
6. Pregnancy (women of childbearing age who have a positive pregnancy test) or lactating women;
If you have such a patient, please contact Chief Physician Zhu Lingjun or Deputy Chief Physician Liu Yiqian, please send medical history data to syqACTL@126.com (it is best to send pathology report, imaging report of recent disease progress, and detailed treatment in the past The medical history and medical history are sent to the mailbox to facilitate our screening. Those who meet the criteria will have the drug research secretary proactively reply), or call the drug research secretary, teacher Wu, 18251826423 for consultation, we will help you arrange the screening time (working hours Monday to Friday at 9 am :00-11:00 PM 2:30-4:30), you can also bring all the medical history data (discharge summary, pathology report, recent CT film, etc.) to the Oncology Clinic of Jiangsu Provincial People's Hospital. Chief Physician Zhu Lingjun: Clinic room 16 on the third floor of the outpatient clinic every Monday morning.
Information source: Official website of Jiangsu Provincial People's Hospital
Information address: http://www.jsph.org.cn/tongzhigonggao/2017-08-14/19291.html
