Lung adenocarcinoma IIB
Conditions
Interventions
Low frequency group:After randomization, patients received thymalfasin therapy with a dose of 1.6mg/ time, subcutaneous injection, twice a week, until the patient developed disease progression or int
High frequency group:After randomization, patients were treated with thymalfasin therapy at a dose of 1.6mg/ time, subcutaneous injection, and once every other day until the occurrence of disease rec
Sponsors
Shanghai Changhai Hospital
Eligibility
Sex/Gender
All
Age
50 Years to 75 Years
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following criteria to participate in the trial: 1. Radical lung cancer resection (R0) was performed, and the postoperative pathology confirmed lung adenocarcinoma, staging stage IIB, according to TNM staging system of UICC eighth edition (appendix 1); 2. Complete 4 cycles of pemetrexed combined with platinum (cisplatin or carboplatin) adjuvant chemotherapy after radical resection; 3. The new time interval between the end of chemotherapy and the first thymus test was 2-6 weeks; 4. Expected survival time >= 6 months; 5. Men and women, 50-70 years old; 6. Physical condition score ECOG 0-1; 7. The main organ functions normally, that is, the following criteria are met (erythropoietin (EPO)/thrombogenin (TPO)/granulocyte colony-stimulating factor (g-csf) were not used within 14 days to promote the generation of tri-line drugs or blood transfusion) : (1) blood routine examination standards should meet: The WBC acuity 4.0 x 10^9 / L; The ANC acuity 1.5 x 10^9 / L; PLT acuity 100 x 10^9 / L; HB 90 g/L or higher. (2) biochemical examination shall meet the following standards: TBIL = 60 ml/min(Cockcroft-Gault) CCr (ml/min)= (male) (140- age) x weight (kg)/72 x creatinine (mg/dL) (female) (140- age) x weight (kg)/85 x creatinine (mg/dL) 8. No metastatic/recurrent tumor lesions were found on CT or MRI at baseline (after adjuvant chemotherapy); 9. No history of immune-related diseases, such as systemic lupus erythematosus, autoimmune hepatitis, etc.; Women of child-bearing age must undergo a negative pregnancy test (serum or urine) within 7 days prior to enrollment and be willing to use appropriate methods of contraception during the trial and within 6 months after the last dose of the test drug.For men, agree to use appropriate methods of contraception during the trial and within 6 months of the last administration of the trial drug; 11. Sign informed consent; 12. Good compliance, voluntary follow-up, treatment, laboratory examination and other research steps as planned.
Exclusion criteria
Exclusion criteria: Patients who meet any of the following criteria should be excluded from this study: 1. Patients with small cell lung cancer, squamous cell carcinoma and large cell carcinoma confirmed by postoperative pathology; 2. Patients with any acute or chronic disease or mental disorder or abnormal laboratory examination, which may increase the risk of participating in the study or study medication, or affect the study results, are considered unfit to participate in the study by the researchers. 3. Receive other antitumor therapies, including chemotherapy, radiotherapy, targeted and immunotherapy; 4. With history of other malignant tumors within five years, except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix; 5. Pregnant or nursing women; 6. Have a history of substance abuse and cannot be cured or have a mental disorder; 7. Participated in clinical trials of other drugs within four weeks; 8. Patients with allergies and known or suspected allergies to the study drugs; 9. People who the researchers think are not suitable to participate in this experiment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| peripheral blood T lymphocyte subsets count; | — |
Secondary
| Measure | Time frame |
|---|---|
| Peripheral blood cytokines;concentration of thymalfasin in peripheral blood; | — |
Countries
China
Contacts
Public ContactGao Shen
Shanghai Changhai Hospital
Outcome results
None listed