Microwave Ablation in Combination With Camrelizumab Versus Camrelizumab in Metastatic Non-small-cell Lung Cancer
NCT ID: NCT04102982
Last Updated: 2020-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
200 participants
INTERVENTIONAL
2019-11-01
2022-02-28
Brief Summary
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Detailed Description
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The primary end point is overall survival. The second end points include progression free survival, objective response rate and safety.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
Arm 2：Patients in the camrelizumab group were treated with camrelizumab with the dose of 200mg on day 1, repeated every 21 days.
OTHER
NONE
Study Groups
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Microwave ablation plus camrelizumab group
Patients in the group are treated with Microwave ablation in the primary tumor, followed by camrelizumab.
Camrelizumab plus microwave ablation
In the group, microwave ablation will be administrated to the primary tumors, followed by camrelizumab.
Camrelizumab group
Patients in the group are treated with camrelizumab alone.
Camrelizumab
Patients will be treated with camrelizumab alone.
Interventions
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Camrelizumab
Patients will be treated with camrelizumab alone.
Camrelizumab plus microwave ablation
In the group, microwave ablation will be administrated to the primary tumors, followed by camrelizumab.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
80 Years
ALL
No
Sponsors
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Shandong Provincial Hospital
OTHER_GOV
Responsible Party
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Xin Ye
Head of Section
Principal Investigators
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Xin Ye
Role: PRINCIPAL_INVESTIGATOR
Shandong Provincial Hospital
Locations
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Binzhou Medical University Hospital
Binzhou, Shandong, China
Dezhou People's Hospital
Dezhou, Shandong, China
The Second People's Hospital of Dezhou
Dezhou, Shandong, China
Jinan Military General Hospital
Jinan, Shandong, China
Affliated Hospital of Shandong Academy of Medical Sciences
Jinan, Shandong, China
Shandong Provincial Hospital affliated to Shandong University
Jinan, Shandong, China
Affliated Hospital of Jining Medical University
Jining, Shandong, China
Liaocheng Cancer Hospital
Liaocheng, Shandong, China
Affliated Hospital of Taishan Medical University
Taian, Shandong, China
The People's Liberation Army 88 Hospital
Taian, Shandong, China
Weifang People's Hospital
Weifang, Shandong, China
Yantai Yuhuangding Hospital
Yantai, Shandong, China
Tengzhou center of people's hospital
Zaozhuang, Shandong, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Shandong PH
Identifier Type: -
Identifier Source: org_study_id