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

Overview

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

Full Title of Study: “Shandong Provincial Hospital Affiliated to Shandong University”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 31, 2020

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.

Interventions

  • Drug: Camrelizumab
    • Patients will be treated with camrelizumab alone.
  • Other: Camrelizumab plus microwave ablation
    • In the group, microwave ablation will be administrated to the primary tumors, followed by camrelizumab.

Arms, Groups and Cohorts

  • Active Comparator: Microwave ablation plus camrelizumab group
    • Patients in the group are treated with Microwave ablation in the primary tumor, followed by camrelizumab.
  • Placebo Comparator: Camrelizumab group
    • Patients in the group are treated with camrelizumab alone.

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Shandong Provincial Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Xin Ye, Head of Section – Shandong Provincial Hospital
  • Overall Official(s)
    • Xin Ye, Principal Investigator, Shandong Provincial Hospital
  • Overall Contact(s)
    • Xin Ye, +8653168773171, yexitaian2014@163.com

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.