Microwave Ablation in Combination With Camrelizumab Versus Camrelizumab in Metastatic Non-small-cell Lung Cancer

Study Overview
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Brief Summary
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Patients were randomized to microwave ablation plus camrelizumab group or camrelizumab group.

Detailed Description
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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.

Official Title
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Shandong Provincial Hospital Affiliated to Shandong University

Conditions
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NSCLC Stage IV

Intervention / Treatment
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* Drug: Camrelizumab
* Other: Camrelizumab plus microwave ablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 18 to 75 years old Cytologically or pathologically verified non-small cell lung cancer (NSCLC) Patients with distant metastases or postoperative recurrence EGFR or ALK sensitive mutations are negative (all patients, including non-adenocarcinoma patients) At least one line of platinum-based doublet chemotherapy was administrated Eastern Cancer Cooperative Group（ECOG）Performance Status（PS）of 0 to 1 At least two measurable tumors (in other words a measurable tumor lesion exclusive primary tumors) Asymptomatic brain metastases or symptomatic brain metastases under control 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: Mixed lung cancer contains neuroendocrine tumor, small cell lung cancer or sarcoma Suffering from other malignant tumors within five years EGFR, ALK sensitive mutations are positive or unknown ECOG PS≥2 Uncontrolled pleural effusion or pericardial effusion Uncontrolled symptomatic brain metastases Previously anti-PD-1, anti-PD-L1, anti-CTLA-4 or Car-T immunotherapy severe interstitial pneumonia with severe diffuse dysfunction Autoimmune diseases require long-term hormone therapy patients Patients required consistent application of prednisone Uncontrolled pulmonary infection or antibiotics stopped within 1 month Acute cardiovascular and cerebrovascular diseases such as acute cerebral infarction and acute coronary syndrome within 1 month Patients during pregnancy or lactation Life expectance of 3 months or less

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Microwave ablation plus camrelizumab group<br>Patients in the group are treated with Microwave ablation in the primary tumor, followed by camrelizumab. | Other: Camrelizumab plus microwave ablation<br>* In the group, microwave ablation will be administrated to the primary tumors, followed by camrelizumab.<br>* Other names: Camrelizumab plus MWA;|
| Placebo Comparator: Camrelizumab group<br>Patients in the group are treated with camrelizumab alone. | Drug: Camrelizumab<br>* Patients will be treated with camrelizumab alone.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate | ORR | The proportion of Patients achieved complete response or partial response up to 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | OS | From date of randomization until the date of first documented date of death from any cause，assessed up to 24 months | 
| Progression free survival | OS | 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 | 
| Safety | The adverse events of both microwave and camrelizumab | The proportion and grade of patients had adverse events up to 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Safety, NSCLC, Camrelizumab, Microwave ablation, Overall survival, Progression free survival, Objective response rate