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

October 29, 2020 updated by: Xin Ye, Shandong Provincial Hospital

Shandong Provincial Hospital Affiliated to Shandong University

Patients were randomized to microwave ablation plus camrelizumab group or camrelizumab group.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shandong
      • Binzhou, Shandong, China, +86 256600
        • Recruiting
        • Binzhou Medical university hospital
        • Contact:
      • Dezhou, Shandong, China, +86 253000
        • Recruiting
        • Dezhou People's Hospital
        • Contact:
      • Dezhou, Shandong, China, +86 253000
        • Recruiting
        • The Second People's Hospital of Dezhou
        • Contact:
      • Jinan, Shandong, China, +83 250001
        • Recruiting
        • Jinan Military General Hospital
        • Contact:
      • Jinan, Shandong, China, +86 250001
        • Recruiting
        • Affliated Hospital of Shandong Academy of Medical Sciences
        • Contact:
      • Jinan, Shandong, China, +86053168773172
        • Recruiting
        • Shandong Provincial Hospital affliated to Shandong University
        • Contact:
        • Contact:
      • Jining, Shandong, China, +86 272000
        • Recruiting
        • Affliated Hospital of Jining Medical University
        • Contact:
      • Liaocheng, Shandong, China, +86 252000
        • Recruiting
        • Liaocheng Cancer Hospital
        • Contact:
      • Taian, Shandong, China, +86 271000
        • Recruiting
        • Affliated Hospital of Taishan Medical University
        • Contact:
      • Taian, Shandong, China, +86 271000
        • Recruiting
        • The People's Liberation Army 88 Hospital
        • Contact:
      • Weifang, Shandong, China, +86 262000
        • Recruiting
        • Weifang People's Hospital
        • Contact:
          • Guo hua Yu, M.D
          • Phone Number: +86 13685368817
          • Email: ghyry@126.com
      • Yantai, Shandong, China, +86 264000
        • Recruiting
        • Yantai Yuhuangding Hospital
        • Contact:
      • Zaozhuang, Shandong, China, +86 277000
        • Recruiting
        • Tengzhou center of people's hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate
Time Frame: The proportion of Patients achieved complete response or partial response up to 16 weeks
ORR
The proportion of Patients achieved complete response or partial response up to 16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From date of randomization until the date of first documented date of death from any cause，assessed up to 24 months
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
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
Time Frame: The proportion and grade of patients had adverse events up to 24 months
The adverse events of both microwave and camrelizumab
The proportion and grade of patients had adverse events up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shandong Provincial Hospital

Investigators

  • Principal Investigator: Xin Ye, Shandong Provincial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2019

Primary Completion (Anticipated)

October 31, 2021

Study Completion (Anticipated)

February 28, 2022

Study Registration Dates

First Submitted

September 22, 2019

First Submitted That Met QC Criteria

September 23, 2019

First Posted (Actual)

September 25, 2019

Study Record Updates

Last Update Posted (Actual)

November 2, 2020

Last Update Submitted That Met QC Criteria

October 29, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Shandong PH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Principle of confidentiality

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on NSCLC Stage IV

Clinical Trials on Camrelizumab plus microwave ablation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Moldova

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe