Microwave Ablation in Combination With Camrelizumab Versus Camrelizumab in Metastatic Non-small-cell Lung Cancer
- Conditions
- NSCLC Stage IV
- Interventions
- Other: Camrelizumab plus microwave ablation
- Registration Number
- NCT04102982
- Lead Sponsor
- Shandong Provincial Hospital
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 200
- 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
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Microwave ablation plus camrelizumab group Camrelizumab plus microwave ablation Patients in the group are treated with Microwave ablation in the primary tumor, followed by camrelizumab. Camrelizumab group Camrelizumab Patients in the group are treated with camrelizumab alone.
- Primary Outcome Measures
Name Time Method Objective response rate The proportion of Patients achieved complete response or partial response up to 16 weeks ORR
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (13)
Binzhou Medical University Hospital
🇨🇳Binzhou, Shandong, China
Liaocheng Cancer Hospital
🇨🇳Liaocheng, Shandong, China
Jinan Military General Hospital
🇨🇳Jinan, Shandong, China
Affliated Hospital of Jining Medical University
🇨🇳Jining, Shandong, China
The Second People's Hospital of Dezhou
🇨🇳Dezhou, Shandong, China
Affliated Hospital of Shandong Academy of Medical Sciences
🇨🇳Jinan, Shandong, China
Dezhou People's Hospital
🇨🇳Dezhou, Shandong, China
Shandong Provincial Hospital affliated to Shandong University
🇨🇳Jinan, Shandong, China
Yantai Yuhuangding Hospital
🇨🇳Yantai, Shandong, China
Affliated Hospital of Taishan Medical University
🇨🇳Taian, Shandong, China
The People's Liberation Army 88 Hospital
🇨🇳Taian, Shandong, China
Tengzhou center of people's hospital
🇨🇳Zaozhuang, Shandong, China
Weifang People's Hospital
🇨🇳Weifang, Shandong, China