small cell lung cancer
Conditions
Interventions
Test group:cord blood-derived NK cells
Sponsors
The First Central Hospital of Tianjin
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Male or female, aged 18 years or above; 2. ECOG score 0-2; 3. metastatic or extensive-stage small cell lung cancer (SCLC) confirmed by histology or cytology, followed by 4 cycles of platinum-based doublet-chemotherapy with at least 2 cycles of immune checkpoint inhibitor plus chemotherapy. And stable disease (SD), partial response (PR), or complete response (CR) as assessed by imaging (RECIST1.1 criteria) after the last treatment. (The checkpoint inhibitors used were those recommended by the NCCN, ESMO, and CSCO guidelines for extensivestage SCLC, including but not limited to: Duvalumab, atezolizumab, slulizumab, adbelimumab, toripalimab, etc.); 4. PD-L1 expression TPS >= 1%; 5. After standard concurrent chemoradiotherapy, LS-SCLC could be enrolled in this study if sensitive relapse (relapse more than 6 months after the end of first-line treatment) progressed to extensive-stage (Ed) and met the inclusion criteria No.3; 6. At least 4 weeks after major surgery or trauma, and the wound must be completely healed; At least 1 week after minor surgical procedures or trauma (e.g., tissue biopsy or fine-needle aspiration); 7. Objective measurable lesions according to RECIST 1.1 criteria; 8. predicted survival time >=1 year; 9. bone marrow function: ANC >=1.5×10^9/L, HB >=70 g/L (blood transfusion allowed), PLT >=80×10^9/L; 10. Liver function: ALT = 60 ml/min/1.73m^2; 11. no history of autoimmune diseases or current autoimmune diseases; 12. The subjects voluntarily participated in the study, signed the informed consent form, communicated well with the investigators, and completed the study in accordance with the protocol.
Exclusion criteria
Exclusion criteria: 1. participating in another clinical trial or using another investigational drug or device within 4 weeks of the first treatment; 2. Patients with active or untreated CNS metastases detected by CT scan or MRI during screening and previous imaging evaluation, who had previously treated asymptomatic CNS metastases, were eligible to participate in the study if they met all of the following criteria: No corticosteroid was used to treat CNS disease, and no progression was found in imaging studies from the end of CNS-directed therapy to the screening period. Patients with new asymptomatic CNS metastases detected on screening imaging were required to undergo radiation therapy and/or CNS metastasis surgery. 3. symptomatic third space effusion requiring repeated drainage (e.g., once every 4 weeks or less) such as pericardial, pleural or peritoneal effusion that cannot be controlled by pumping or other treatments; 4. vaccination with live vaccine within 30 days before the first dose of study drug. Live vaccines include but are not limited to: measles, mumps, minute needle, varicella/herpes zoster, rabies, Bacillus Calmette-Guerin, typhoid vaccine, etc. Seasonal injectable influenza vaccine is generally inactivated virus vaccine and permitted for use. 5. patients were known to have other malignancies that were progressing or required aggressive treatment within the past 3 years (except in situ cancer or localized prostate cancer detected by PSA testing); 6. major surgery, open surgical biopsy, or severe traumatic injury within 28 days before enrollment; 7. clinically relevant or prior interstitial lung disease; 8. severe unhealed wounds, ulcers, or fractures; 9. have an autoimmune disease requiring systemic treatment within the past 2 years; 10. unstable systemic comorbidities (active infection, moderate-to-severe chronic obstructive pulmonary disease, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within 6 months, cerebrovascular accident, pulmonary embolism or untreated history of grade 3 deep vein thrombosis (DVT), severe mental disorder requiring medical control, liver, Renal or other metabolic diseases, neuropsychiatric disorders such as Alzheimer's disease); 11. Concomitant diseases that, according to the investigator's judgment, seriously endanger patient safety or prevent patients from completing the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of Overall Response;overall survival;Safety;Immune function-related detecting; | — |
Countries
China
Contacts
Public ContactZhao Zhigang
The First Central Hospital of Tianjin
Outcome results
None listed