Lung Cancer
Conditions
Interventions
Stem cell low dose group:Subcutaneous inject X-ray irradiated umbilical cord adult stem cell 3D microsphere
Stem cell medium dose group:Subcutaneous inject X-ray irradiated umbilical cord adult stem cell 3D microsphere
Stem cell high dose group:Subcutaneous inject X-ray irradiated umbilical cord adult stem cell 3D microsphere
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. aged 18 Years to 70 Years patients voluntarily participate in this study; 2. Signed and dated informed consent with good compliance and follow-up; 3. ECOG PS Scoring: 0~2 point; 4. Diagnosed as advanced (Stage IV) lung cancer, including small cell lung cancer, squamous non-small cell lung cancer and non-squamous non-small cell lung cancer by cytology or histology; Provide detectable specimens (tissue or blood) for genotyping before enrollment; 5. Patients with disease progression after standard treatment: 1) Progression of small-cell lung cancer treated with second-line chemotherapy; 2) Patients with EGFR-sensitive mutations must undergo third-line or above treatment failure, which must include at least one EGFR-TKI treatment failure; 3) Patients with ALK-sensitive mutations must undergo third-line or above treatment failure, which must include at least one ALK-TKI treatment failure; 4) Patients with ROS-1-sensitive mutations must undergo third-line or above treatment failure, which must include at least one ALK-TKI treatment failure; 5) Patients with the wild-type EGFR gene and no positive ALK or ros-1 genes must undergo second-line or above standard treatment failure; 6) Patients must undergo standard PD1/PD-L1 treatment and either fail or refuse this treatment. 6. Participants must have measurable disease, per RECIST 1.1. See Section 11 for the evaluation of measurable disease; 7. Life expectancy is at least 3 months; 8. Participants must have normal organ and marrow function as defined below: Blood routine examination criteria (no blood transfusion and blood products within 14 days, no correction by G-CSF and other hematopoietic stimuli): 1) hemoglobin (HB) =90g/L; 2) neutrophil absolute (ANC) =1.5×10^9/L; 3) platelet (PLT) =90×10^9/L; 4) total bilirubin (TBIL) =1.5 times of upper limit of normal (ULN); 5) alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 ULN, if liver metastasis occurred, ALT and AST < 5 ULN; 6) serum creatinine (Cr) = 1.5 ULN or creatinine clearance rate (CCR)=50mL/min (Cockcroft-Gault formula); 7) INR = 1.5 ULN; 8) PTT = 1.5 ULN; 9) left ventricular ejection fraction (LVEF) = 50%; 10) QTcF = 450ms; 11) alkaline phosphatase = 2.5 ULN; 9. Toxic side effects of previous treatment (except hair loss, etc.) level 1 or return to baseline; 10. The washout period is 4 weeks or 5 half-lives away from the previous anti-tumor therapy or molecular targeted therapy; Palliative radiotherapy must have been completed for at least 2 weeks and chest radiotherapy for at least 3 months; Major surgery must have been completed for at least 4 weeks; 11. Female patients of childbearing age agree that contraceptive measures must be used within the study period and within 18 months after the end of the study period. The serum or urine pregnancy test (HCG sensitivity at least 25 IU/L or equivalent) in Women in childbearing period (WOCBP) must be negative within 72 hours prior to initiation of treatment. Male patients agree to have contraceptive use during the study period and within 18 months after the end of the study period or have had surgical sterilization.
Exclusion criteria
Exclusion criteria: 1. Active brain metastases, cancerous meningitis, spinal cord compression, or imaging CT or MRI screening for brain or pia mater disease. Patients may participate in research if the participants central nervous system (CNS) metastasis can be adequately treated and their neurological symptoms can be restored to baseline at least 2 weeks before enrollment. In addition, participants must have discontinued corticosteroids 4 weeks before enrollment. 2. Accompanied by tumor emergency, need immediate treatment. 3. Participants with clinically active or symptomatic interstitial lung disease, interstitial pneumonitis or immune pneumonia (i.e., affecting activities of daily living or requiring therapeutic intervention) and patients with history of clinically significant interstitial lung disease or radiation pneumonitis. 4. There is currently a peripheral neuropathy of =CTCAE 2 degrees, except for trauma. 5. Clinically significant coagulation abnormalities, or being treated with thrombolysis or anticoagulation. 6. Known history of human immunodeficiency virus (HIV) seropositivity. Active or chronic hepatitis C or/and hepatitis B infection. 7. The pathological type was mixed type, or accompanied by other malignant tumors. 8. Patients with active, known or suspected autoimmune diseases. 9. Participants who required systemic corticosteroid (equivalent to >10 mg prednisone/day) or other immunomodulator (interleukin-2, IFN-, IFN-, cyclosporine, g-csf, mTOR inhibitor) treatment within 28 days prior to enrollment. 10. Patients with clinically significant, uncontrolled cardiovascular disease or cardiac functional damage, such as: i) clinically significant cardiovascular disease, such as congestive heart failure or uncontrolled arterial hypertension, is defined as resting > 140/100 mmHg (mean of 3 consecutive measurements); ii) history of clinically significant arrhythmias, atrial fibrillation and/or conduction abnormalities (< 6 months before screening) or current evidence, such as congenital long QT interstitial syndrome, complete atrioventricular block at grade 2, or hypokalemia at CTCA level 3; iii) patients who had a history of acute coronary syndrome or current evidence (including myocardial infarction, unstable angina, CABG, coronary angioplasty or stent implantation) within 6 months before enrollment; iv) complete left bundle branch block; v) Right bundle branch block and left anterior branch block; 11. Women in pregnancy or lactation. Pregnancy is defined as between conception and termination of pregnancy. 12. Persons who have been forcibly detained for the treatment of mental illness. Or other psychopaths deemed unfit for enrollment. 13. Patients are difficult to communicate or to follow up for long periods of time. 14. Patients were diagnosed with disease which will severely endanger the security of patients or influence the completion of this research, or patients with other situations are not suitable for the study according to the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| DLT; | — |
Secondary
| Measure | Time frame |
|---|---|
| RR;DCR;DOR;Time to first response;PFS;OS; | — |
Countries
China
Contacts
Public ContactMeijuan Huang
West China Hospital, Sichuan University
Outcome results
None listed