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Patients were randomized to microwave ablation plus camrelizumab group or camrelizumab group.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Microwave ablation plus camrelizumab group | Active Comparator | Patients in the group are treated with Microwave ablation in the primary tumor, followed by camrelizumab. |
|
| Camrelizumab group | Placebo Comparator | Patients in the group are treated with camrelizumab alone. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Camrelizumab | Drug | Patients will be treated with camrelizumab alone. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate | ORR | The proportion of Patients achieved complete response or partial response up to 16 weeks |
| 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 |
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Inclusion Criteria:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xin Ye | Contact | +8653168773171 | yexitaian2014@163.com | |
| Zhigang Wei | Contact | +8653168773171 | weizhigang321321@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Xin Ye | Shandong Provincial Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Binzhou Medical University Hospital | Recruiting | Binzhou | Shandong | +86 256600 | China |
Principle of confidentiality
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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.
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| Camrelizumab plus microwave ablation |
| Other |
In the group, microwave ablation will be administrated to the primary tumors, followed by camrelizumab. |
|
|
| 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 |
| Dezhou People's Hospital | Recruiting | Dezhou | Shandong | +86 253000 | China |
|
| The Second People's Hospital of Dezhou | Recruiting | Dezhou | Shandong | +86 253000 | China |
|
| Jinan Military General Hospital | Recruiting | Jinan | Shandong | +83 250001 | China |
|
| Affliated Hospital of Shandong Academy of Medical Sciences | Recruiting | Jinan | Shandong | +86 250001 | China |
|
| Shandong Provincial Hospital affliated to Shandong University | Recruiting | Jinan | Shandong | +86053168773172 | China |
|
| Affliated Hospital of Jining Medical University | Recruiting | Jining | Shandong | +86 272000 | China |
|
| Liaocheng Cancer Hospital | Recruiting | Liaocheng | Shandong | +86 252000 | China |
|
| Affliated Hospital of Taishan Medical University | Recruiting | Taian | Shandong | +86 271000 | China |
|
| The People's Liberation Army 88 Hospital | Recruiting | Taian | Shandong | +86 271000 | China |
|
| Weifang People's Hospital | Recruiting | Weifang | Shandong | +86 262000 | China |
|
| Yantai Yuhuangding Hospital | Recruiting | Yantai | Shandong | +86 264000 | China |
|
| Tengzhou center of people's hospital | Recruiting | Zaozhuang | Shandong | +86 277000 | China |
|
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C000631724 | camrelizumab |
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