Microwave Ablation in Combination With Camrelizumab Versus Camrelizumab in Metastatic Non-small-cell Lung Cancer
MWA in NSCLC
Shandong Provincial Hospital Affiliated to Shandong University
1 other identifier
interventional
200
1 country
13
Brief Summary
Patients were randomized to microwave ablation plus camrelizumab group or camrelizumab group.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2019
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 22, 2019
CompletedFirst Posted
Study publicly available on registry
September 25, 2019
CompletedStudy Start
First participant enrolled
November 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2022
CompletedNovember 2, 2020
October 1, 2020
2 years
September 22, 2019
October 29, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Objective response rate
ORR
The proportion of Patients achieved complete response or partial response up to 16 weeks
Secondary Outcomes (3)
Overall survival
From date of randomization until the date of first documented date of death from any cause，assessed up to 24 months
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
Safety
The proportion and grade of patients had adverse events up to 24 months
Study Arms (2)
Microwave ablation plus camrelizumab group
ACTIVE COMPARATORPatients in the group are treated with Microwave ablation in the primary tumor, followed by camrelizumab.
Camrelizumab group
PLACEBO COMPARATORPatients in the group are treated with camrelizumab alone.
Interventions
In the group, microwave ablation will be administrated to the primary tumors, followed by camrelizumab.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Binzhou Medical University Hospital
Binzhou, Shandong, +86 256600, China
Dezhou People's Hospital
Dezhou, Shandong, +86 253000, China
The Second People's Hospital of Dezhou
Dezhou, Shandong, +86 253000, China
Jinan Military General Hospital
Jinan, Shandong, +83 250001, China
Affliated Hospital of Shandong Academy of Medical Sciences
Jinan, Shandong, +86 250001, China
Shandong Provincial Hospital affliated to Shandong University
Jinan, Shandong, +86053168773172, China
Affliated Hospital of Jining Medical University
Jining, Shandong, +86 272000, China
Liaocheng Cancer Hospital
Liaocheng, Shandong, +86 252000, China
Affliated Hospital of Taishan Medical University
Taian, Shandong, +86 271000, China
The People's Liberation Army 88 Hospital
Taian, Shandong, +86 271000, China
Weifang People's Hospital
Weifang, Shandong, +86 262000, China
Yantai Yuhuangding Hospital
Yantai, Shandong, +86 264000, China
Tengzhou center of people's hospital
Zaozhuang, Shandong, +86 277000, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xin Ye
Shandong Provincial Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of Section
Study Record Dates
First Submitted
September 22, 2019
First Posted
September 25, 2019
Study Start
November 1, 2019
Primary Completion
October 31, 2021
Study Completion
February 28, 2022
Last Updated
November 2, 2020
Record last verified: 2020-10
Data Sharing
- IPD Sharing
- Will not share
Principle of confidentiality