NSCLC
Conditions
Interventions
Experimental group:PD-1 antibody+ Cordycepin treatment
Sponsors
Changzhou First People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Sign the written informed consent; 2) Male or female aged = 18 years and = 75 years; 3) Patients with advanced non-small cell lung cancer confirmed pathologically by histology or cytology and retreated have measurable lesions; 4) The physical status score (ECOG PS) of the eastern tumor cooperative group was 0~2; 5) Estimated survival time = 3 months; 6) The laboratory results during screening must meet the following requirements: a) Blood routine examination: absolute neutrophil count (ANC) = 1.0 x 10^9/L, platelet count (PLT) = 100 x 10^9/L, hemoglobin (HGB) = 90 g/L (no blood transfusion or erythropoietin dependence within 7 days); b) Liver function: total bilirubin (TBIL) = 1.5 times the upper limit of normal value (ULN); The alanine aminotransferase (ALT) and aspartate aminotransferase (AST) of subjects without liver metastasis were = 2.5 times ULN, and the ALT and AST of subjects with liver metastasis were = 5 times ULN; c) Renal function: serum creatinine (Cr) = 1.5 times ULN or Cr clearance = 60mL/min (Cockcroft Gault formula), and urine routine test results showed that urine egg (UPRO)<2+or 24-hour urine egg ration<1g; 7) For female subjects of childbearing age, they should test negative for pregnancy in urine or serum within 3 days before receiving the first study drug administration (cycle 1, day 1). If the urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is required; 8)Expected good compliance.
Exclusion criteria
Exclusion criteria: 1) Patients who have used cordycepin and PD-1/PD-L1 monoclonal antibody before; 2) Gene screening: patients with EGFR mutation or ALK mutation; 3) Other malignant tumors (except clinically cured cervical carcinoma in situ, basal cell or squamous cell carcinoma, papillary thyroid carcinoma) have occurred or are currently suffering from within 5 years; 4) Have received chemotherapy, radiotherapy or other experimental anti-cancer therapy within 4 weeks before treatment; Those who have received local radiotherapy in the past can be divided into two groups if the following conditions are met: the end of radiotherapy is more than 4 weeks from the start of the study treatment (more than 2 weeks for brain radiotherapy), and the target lesions selected in this study are not in the radiotherapy area, or the target lesions are in the radiotherapy area, but the progress has been confirmed. 5) Within 2 weeks before the first administration, he has received systematic systemic treatment with Chinese herbal medicine with anti-tumor indications or immunomodulatory drugs (including thymosin, interferon, interleukin, except for local use to control pleural effusion); 6) Receive live attenuated vaccine within 4 weeks before the first administration (or plan to receive live vaccine during the study); Note: It is allowed to receive inactivated virus vaccine for injection against seasonal influenza within 4 weeks before the first administration; However, live attenuated influenza vaccine is not allowed; 7) Large and medium-sized surgery, or unhealed surgical incision, ulcer or fracture within 4 weeks before the first administration; 8) Within 7 days before the first administration, the patient is receiving any other form of immunosuppressive therapy, excluding local glucocorticoids or systemic glucocorticoids of physiological dose (= 10 mg/day of prednisone or equivalent dose of drugs) through nasal spray, inhalation or other routes; 9) There was a history of non infectious pneumonia requiring glucocorticoid treatment within 1 year before the first administration or there was interstitial lung disease currently; 10) Active autoimmune diseases requiring systemic treatment (such as the use of disease relieving drugs, corticosteroids or immunosuppressants) occurred within 2 years before the first administration. Allowing the use of alternative therapies (such as thyroxine, insulin or physiological corticosteroids for adrenal or pituitary insufficiency); 11) Asymptomatic central nerve metastasis; Patients with brain metastases whose symptoms are stable = 2 weeks after treatment can participate in this study as long as they meet all the following criteria: there are measurable lesions outside the central nervous system; No midbrain, pons, cerebellum, medulla oblongata or spinal cord metastasis; No previous history of intracranial hemorrhage; Hormone therapy was stopped 7 days before the first dose of study drug; 12) Before starting the treatment, the patient has not fully recovered from the toxicity and/or complications caused by any intervention (i.e. = Level 1 or reaching the baseline, excluding fatigue or hair loss); 13) There is clinically uncontrollable third space effusion (such as pleural effusion/pericardial effusion); 14) Any unstable systemic disease: including but not limited to active infection, unstable angina, cerebrovascular accident or transient cerebral ischemia (within 6 months before screening), myocardial infarction (within 6 months before scr
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of life score;Overall survival, OS;Objective response rate, ORR;Disease control rate, DCR; | — |
Countries
China
Contacts
Public ContactLi Chong
Changzhou First People's Hospitalchow University
Outcome results
None listed