Non-small cell lung cancer
Conditions
Interventions
Case series:microwave ablation of local tumors combined with adoptive cellular immunotherapy
Sponsors
Beijing Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Volunteer to participate in this study, and sign a written informed consent before the study, good compliance; 2. Aged >=18 years; 3. Histologically or cytologically proven advanced (stage IIIB or IV) non-small cell lung cancer (NSCLC) with failure of standard treatment (e.g. The patient could not tolerate surgical resection due to poor cardiopulmonary function or advanced age. Refused surgical resection), or no effective standard treatment (such as peripheral lung cancer with malignant pleural effusion after pleural biopsy fixation), and the condition does not require urgent management; 4. Physical condition ECOG/Zubrod score 0 or 1; 5. According to RECIST1.1, there was at least one measurable lesion in addition to the ablation site. Limited extrapulmonary disease, including abdominal, pelvic, skeletal or local lymph node metastases, is permitted; 6. Patients must fully recover from these effects more than four weeks after major surgery or the completion of the last dose of chemotherapy, radiation, or investigational therapy; 7. Life expectancy is at least 6 months; 8. The main organs are basically normal, that is, they meet the following criteria: (1) blood routine examination standards should meet: HB>=90g/L (no blood transfusion within 14 days); (2) the WBC acuity 3.0 x 10^9/L; (3) PLT acuity 80 x 10^9/L; (2) blood biochemical examination shall meet the following standards: TBIL=60ml/min; (3) cardiac doppler ultrasound evaluation: left ventricular ejection fraction (LVEF) >=low limit of normal (50%); 9. Fertile women and men agree to use effective methods of contraception from screening to the end of the trial.
Exclusion criteria
Exclusion criteria: 1. Patients with no good control of infectious and radioactive inflammation around the lesion, skin infection and ulceration at the puncture site, and malignant pleural effusion on the same side of the ablation lesion; 2. Activity and untreated central nervous system metastases (including those found on MRI or CT scans). Asymptomatic, treated patients with metastatic disease, or whose lesions show stability for more than 2 months, are eligible; 3. Extensive extrapulmonary metastasis, expected survival 160mmHg, diastolic blood pressure > 100mmHg); (6) A history of angina attack and cerebral ischemia in the last 3 months. Serious pulmonary diseases such as severe pulmonary fibrosis (especially drug pulmonary fibrosis), interstitial pulmonary disease >=2 degrees, or active pulmonary diseases (interstitial pneumonia, pneumonia, obstructive pulmonary disease, asthma) or active pulmonary tuberculosis; 3. liver diseases such as decompensated liver disease, chronic active hepatitis, etc.; Poor control of diabetes (fasting blood glucose (FBG) > 10mmol/L); (5) urine routine indicated that urine protein >=++, and confirmed that 24-hour urine protein quantitative > 1.0g; Severe anemia, dehydration and nutrient metabolism serious disorder, unable to correct or improve in a short period of time, activity or failure to control serious infections, high fever (>38.5 degree C); 5. Organ dysfunction; 6. Those with severe bleeding tendency, platelets less than 50×109 /L and serious disorder of coagulation function. Anticoagulant therapy and/or antiplatelet drugs should be discontinued for at least 5d-7d before percutaneous ablation; 7. Has a history of psychotropic substance abuse and cannot be cured or has mental disorders; 8. 4 subjects who have participated in clinical trials of other anti-tumor drugs within weeks or have received anti-tumor therapies such as chemotherapy, radiotherapy, targeted therapy or major surgery; 9. A history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency, or a history of organ transplantation; 10. Pregnant and nursing women; 11. Patients requiring long-term glucocorticoid therapy; 12. Any psychological, familial, social or geographical conditions that may impede compliance with the study programme and subsequent schedules; 13. In the judgment of the investigator, there is a serious risk to the subject's safety or an accompanying disease that affects the subject's ability to complete the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| effectiveness; | — |
Countries
China
Contacts
Public ContactJie Ma Xiaoguang Li
Beijing Hospital
Outcome results
None listed