Microwave Ablation in Combination With Camrelizumab Versus Camrelizumab in Metastatic Non-small-cell Lung Cancer

Last updated: October 29, 2020
Sponsor: Shandong Provincial Hospital
Overall Status: Active - Recruiting

Phase

2

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT04102982
Shandong PH
  • Ages 18-80
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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, includingnon-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 exclusiveprimary tumors)
  8. Asymptomatic brain metastases or symptomatic brain metastases under control
  9. If treated with irradiation,at least one month interval between radiation andrandomization 10)Cardiopulmonary function, laboratory test indicators without ablationor chemotherapy contraindications
  1. Informed conssent can be obtained 12) Sufficient tissue specimens for PD-L1 or TMB orblood samples were provided (1 week before treatment, 1 week after ablation, and once everytwo months for immune evaluation) for subsequent analysis

Exclusion

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 infarctionand acute coronary syndrome within 1 month
  13. Patients during pregnancy or lactation
  14. Life expectance of 3 months or less

Study Design

Total Participants: 200
Study Start date:
November 01, 2019
Estimated Completion Date:
February 28, 2022

Study 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.

Connect with a study center

  • Binzhou Medical University Hospital

    Binzhou, Shandong +86 256600
    China

    Active - Recruiting

  • Dezhou People's Hospital

    Dezhou, Shandong +86 253000
    China

    Active - Recruiting

  • The Second People's Hospital of Dezhou

    Dezhou, Shandong +86 253000
    China

    Active - Recruiting

  • Affliated Hospital of Shandong Academy of Medical Sciences

    Jinan, Shandong +86 250001
    China

    Active - Recruiting

  • Jinan Military General Hospital

    Jinan, Shandong +83 250001
    China

    Active - Recruiting

  • Shandong Provincial Hospital affliated to Shandong University

    Jinan, Shandong +86053168773172
    China

    Active - Recruiting

  • Affliated Hospital of Jining Medical University

    Jining, Shandong +86 272000
    China

    Active - Recruiting

  • Liaocheng Cancer Hospital

    Liaocheng, Shandong +86 252000
    China

    Active - Recruiting

  • Affliated Hospital of Taishan Medical University

    Taian, Shandong +86 271000
    China

    Active - Recruiting

  • The People's Liberation Army 88 Hospital

    Taian, Shandong +86 271000
    China

    Active - Recruiting

  • Weifang People's Hospital

    Weifang, Shandong +86 262000
    China

    Active - Recruiting

  • Yantai Yuhuangding Hospital

    Yantai, Shandong +86 264000
    China

    Active - Recruiting

  • Tengzhou center of people's hospital

    Zaozhuang, Shandong +86 277000
    China

    Active - Recruiting

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