Clinical Trials /

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

NCT04102982

Description:

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

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

URL:

https://clinicaltrials.gov/show/NCT04102982

Trial Eligibility

Document

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

  • NSCLC Stage IV

Interventions

DrugSynonymsArms
CamrelizumabCamrelizumab 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

NameTypeDescriptionInterventions
Microwave ablation plus camrelizumab groupActive ComparatorPatients in the group are treated with Microwave ablation in the primary tumor, followed by camrelizumab.
    Camrelizumab groupPlacebo ComparatorPatients in the group are treated with camrelizumab alone.
    • Camrelizumab

    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