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Microwave Ablation in Combination With Camrelizumab Versus Camrelizumab in Metastatic Non-small-cell Lung Cancer (MWA in NSCLC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04102982
Recruitment Status : Not yet recruiting
First Posted : September 25, 2019
Last Update Posted : October 1, 2019
Sponsor:
Information provided by (Responsible Party):
Xin Ye, Shandong Provincial Hospital

Brief Summary:
Patients were randomized to microwave ablation plus camrelizumab group or camrelizumab group.

Condition or disease Intervention/treatment Phase
NSCLC Stage IV Drug: Camrelizumab Other: Camrelizumab plus microwave ablation Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Arm 1: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.

Arm 2:Patients in the camrelizumab group were treated with camrelizumab with the dose of 200mg on day 1, repeated every 21 days.

Masking: None (Open Label)
Primary Purpose: Other
Official Title: Shandong Provincial Hospital Affiliated to Shandong University
Estimated Study Start Date : November 1, 2019
Estimated Primary Completion Date : October 31, 2020
Estimated Study Completion Date : February 28, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Microwave ablation plus camrelizumab group
Patients in the group are treated with Microwave ablation in the primary tumor, followed by camrelizumab.
Other: Camrelizumab plus microwave ablation
In the group, microwave ablation will be administrated to the primary tumors, followed by camrelizumab.
Other Name: Camrelizumab plus MWA

Placebo Comparator: Camrelizumab group
Patients in the group are treated with camrelizumab alone.
Drug: Camrelizumab
Patients will be treated with camrelizumab alone.




Primary Outcome Measures :
  1. Objective response rate [ Time Frame: The proportion of Patients achieved complete response or partial response up to 16 weeks ]
    ORR


Secondary Outcome Measures :
  1. 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 ]
    OS

  2. 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 ]
    OS

  3. Safety [ Time Frame: The proportion and grade of patients had adverse events up to 24 months ]
    The adverse events of both microwave and camrelizumab



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04102982


Contacts
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Contact: Xin Ye +8653168773171 yexitaian2014@163.com
Contact: Zhigang Wei +8653168773171 weizhigang321321@163.com

Locations
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China, Shandong
Binzhou Medical University Hospital
Binzhou, Shandong, China, +86 256600
Dezhou People's Hospital
Dezhou, Shandong, China, +86 253000
The Second People's Hospital of Dezhou
Dezhou, Shandong, China, +86 253000
Jinan Military General Hospital
Jinan, Shandong, China, +83 250001
Affliated Hospital of Shandong Academy of Medical Sciences
Jinan, Shandong, China, +86 250001
Shandong Provincial Hospital affliated to Shandong University
Jinan, Shandong, China, +86053168773172
Affliated Hospital of Jining Medical University
Jining, Shandong, China, +86 272000
Liaocheng Cancer Hospital
Liaocheng, Shandong, China, +86 252000
Affliated Hospital of Taishan Medical University
Taian, Shandong, China, +86 271000
The People's Liberation Army 88 Hospital
Taian, Shandong, China, +86 271000
Weifang People's Hospital
Weifang, Shandong, China, +86 262000
Yantai Yuhuangding Hospital
Yantai, Shandong, China, +86 264000
Tengzhou center of people's hospital
Zaozhuang, Shandong, China, +86 277000
Sponsors and Collaborators
Shandong Provincial Hospital
Investigators
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Principal Investigator: Xin Ye Shandong Provincial Hospital

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Responsible Party: Xin Ye, Head of Section, Shandong Provincial Hospital
ClinicalTrials.gov Identifier: NCT04102982    
Other Study ID Numbers: Shandong PH
First Posted: September 25, 2019    Key Record Dates
Last Update Posted: October 1, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Principle of confidentiality

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xin Ye, Shandong Provincial Hospital:
NSCLC
Camrelizumab
Microwave ablation
Overall survival
Progression free survival
Objective response rate
Safety