Status:
UNKNOWN
Microwave Ablation in Combination With Camrelizumab Versus Camrelizumab in Metastatic Non-small-cell Lung Cancer
Lead Sponsor:
Shandong Provincial Hospital
Conditions:
NSCLC Stage IV
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
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 f...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2022
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04102982
Start Date
November 1 2019
End Date
February 28 2022
Last Update
November 2 2020
Active Locations (13)
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1
Binzhou Medical University Hospital
Binzhou, Shandong, China, +86 256600
2
Dezhou People's Hospital
Dezhou, Shandong, China, +86 253000
3
The Second People's Hospital of Dezhou
Dezhou, Shandong, China, +86 253000
4
Jinan Military General Hospital
Jinan, Shandong, China, +83 250001