Breat Cancer
Conditions
Interventions
Experimental group: DC-CIK cell therapy
Sponsors
Fujian Cancer Hospital
Eligibility
Sex/Gender
All
Age
20 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1) Understand and sign the informed consent form and comply with the requirements of this study prior to any steps related to this study; 2) Aged 20-70 years, gender unlimited; 3) The patients were treated with modified radical mastectomy or breast conserving surgery before admission. According to the 2018 edition of breast cancer diagnosis and treatment standard issued by China Health Commission, it was diagnosed as breast cancer by pathology. The routine treatment after operation was arranged according to the specific situation of the patients; 4) Expected survival time >=1 year; 5) ECOG = 3 x 10^9/L Neutrophils > 1.5 x 10^9 / L, Hemoglobin >= 85g / L, Platelet >= 50 x 10^9 / L, PT normal or extended time < 3 seconds Urea nitrogen and creatinine <= 1.5 times the upper limit of normal value.
Exclusion criteria
Exclusion criteria: 1) Pregnant women, lactating women or those who plan to be pregnant within the next year; 2) Allergic constitution, history of allergy to blood products, known allergy to test products; 3) In half a year, I have systematically or long-term applied immunomodulators such as interferon, thymosin, traditional Chinese medicine (single medicine such as Chaihu, Huaishan, Huangqi, ginseng, etc., compound medicine such as Yupingfeng powder, etc.) and immunosuppressive drugs such as adrenocortical hormone, etc.; systematic or long-term application refers to the continuous and standardized use of immunomodulators for more than three months, and the continuous and standardized use of immunosuppressive drugs More than 1 month; 4) Patients who have received any cell therapy within half a year (including NK, CIK, DC-CIK, stem cells and other cell therapy); 5) Patients after organ transplantation; patients with uncontrolled infectious diseases; patients with history of immunodeficiency or autoimmune diseases (such as HIV, rheumatoid arthritis, Berger's disease, multiple sclerosis, type 1 diabetes, etc.); 6) Patients with malignant tumors (excluding skin cancer, local prostate cancer or carcinoma in situ of cervix) within 5 years before enrollment; 7) Those with other organ failure; 8) Those with serious mental illness; 9) Screening evidence of drug addiction in the previous year (including alcoholism); 10) Participated in clinical trials of other drugs within 3 months before screening; 11) At the discretion of the investigator, the patient has any serious acute or chronic physical or mental illness, or laboratory abnormality, which may increase the risk of study participation, study administration, or other serious conditions that may affect the interpretation of the study results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Coagulation function;Blood routine;biochemistry;CRP;electrocardiogram;immunity;cytokine; | — |
Secondary
| Measure | Time frame |
|---|---|
| Tumor markers CEA, CA153;Changes in quality of life (KPS/ECOG score); | — |
Countries
China
Contacts
Public ContactQiuhong Zheng
Fujian Cancer Hospital
Outcome results
None listed