Description:
Patients were randomized to microwave ablation plus camrelizumab group or camrelizumab group.
Title
- Brief Title: Microwave Ablation in Combination With Camrelizumab Versus Camrelizumab in Metastatic Non-small-cell Lung Cancer
- Official Title: Shandong Provincial Hospital Affiliated to Shandong University
Clinical Trial IDs
- ORG STUDY ID:
Shandong PH
- NCT ID:
NCT04102982
Conditions
Interventions
Drug | Synonyms | Arms |
---|
Camrelizumab | | Camrelizumab group |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
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. | |
Eligibility Criteria
Inclusion Criteria:
1. Aged 18 to 75 years old
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:
1. Mixed lung cancer contains neuroendocrine tumor, small cell lung cancer or sarcoma
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
Maximum Eligible Age: | 80 Years |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Objective response rate |
Time Frame: | The proportion of Patients achieved complete response or partial response up to 16 weeks |
Safety Issue: | |
Description: | ORR |
Secondary Outcome Measures
Measure: | Overall survival |
Time Frame: | From date of randomization until the date of first documented date of death from any cause,assessed up to 24 months |
Safety Issue: | |
Description: | OS |
Measure: | Progression free survival |
Time Frame: | 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 Issue: | |
Description: | OS |
Measure: | Safety |
Time Frame: | The proportion and grade of patients had adverse events up to 24 months |
Safety Issue: | |
Description: | The adverse events of both microwave and camrelizumab |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Shandong Provincial Hospital |
Trial Keywords
- NSCLC
- Camrelizumab
- Microwave ablation
- Overall survival
- Progression free survival
- Objective response rate
- Safety
Last Updated
November 2, 2020