NSCLC Stage IV
Conditions
Keywords
NSCLC, Camrelizumab, Microwave ablation, Overall survival, Progression free survival, Objective response rate, Safety
Brief summary
Patients were randomized to microwave ablation plus camrelizumab group or camrelizumab group.
Detailed description
Patients in the camrelizumab group were treated with camrelizumab with the dose of 200mg on day 1, repeated every 21 days.Patients in the combination group were treated with MWA in the primary tumor followed by camrelizumab with the dose of 200mg on day 1, repeated every 21 days. The primary end point is overall survival. The second end points include progression free survival, objective response rate and safety.
Interventions
DRUGCamrelizumab
Patients will be treated with camrelizumab alone.
OTHERCamrelizumab plus microwave ablation
In the group, microwave ablation will be administrated to the primary tumors, followed by camrelizumab.
Sponsors
Shandong Provincial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
Arm 1：Patients in the combination group were treated with MWA in the primary tumor followed by camrelizumab with the dose of 200mg on day 1, repeated every 21 days. Arm 2：Patients in the camrelizumab group were treated with camrelizumab with the dose of 200mg on day 1, repeated every 21 days.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Aged 18 to 75 years old 2. Cytologically or pathologically verified non-small cell lung cancer (NSCLC) 3. Patients with distant metastases or postoperative recurrence 4. EGFR or ALK sensitive mutations are negative (all patients, including non-adenocarcinoma patients) 5. At least one line of platinum-based doublet chemotherapy was administrated 6. Eastern Cancer Cooperative Group（ECOG）Performance Status（PS）of 0 to 1 7. At least two measurable tumors (in other words a measurable tumor lesion exclusive primary tumors) 8. Asymptomatic brain metastases or symptomatic brain metastases under control 9. If treated with irradiation，at least one month interval between radiation and randomization 10）Cardiopulmonary function, laboratory test indicators without ablation or chemotherapy contraindications 11\) Informed conssent can be obtained 12) Sufficient tissue specimens for PD-L1 or TMB or blood samples were provided (1 week before treatment, 1 week after ablation, and once every two months for immune evaluation) for subsequent analysis
Exclusion criteria
1. Mixed lung cancer contains neuroendocrine tumor, small cell lung cancer or sarcoma 2. Suffering from other malignant tumors within five years 3. EGFR, ALK sensitive mutations are positive or unknown 4. ECOG PS≥2 5. Uncontrolled pleural effusion or pericardial effusion 6. Uncontrolled symptomatic brain metastases 7. Previously anti-PD-1, anti-PD-L1, anti-CTLA-4 or Car-T immunotherapy 8. severe interstitial pneumonia with severe diffuse dysfunction 9. Autoimmune diseases require long-term hormone therapy patients 10. Patients required consistent application of prednisone 11. Uncontrolled pulmonary infection or antibiotics stopped within 1 month 12. Acute cardiovascular and cerebrovascular diseases such as acute cerebral infarction and acute coronary syndrome within 1 month 13. Patients during pregnancy or lactation 14. Life expectance of 3 months or less
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate | The proportion of Patients achieved complete response or partial response up to 16 weeks | ORR |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | From date of randomization until the date of first documented date of death from any cause，assessed up to 24 months | OS |
| Progression free survival | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months | OS |
| Safety | The proportion and grade of patients had adverse events up to 24 months | The adverse events of both microwave and camrelizumab |
Countries
China
Contacts
Primary ContactXin Ye
Backup ContactZhigang Wei
Outcome results
None listed