CClinicalTrials.gg
Status unknownNCT04102982MWA in NSCLCUpdated Nov 2, 2020

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

A Phase 2 interventional study of Camrelizumab and Camrelizumab plus microwave ablation in NSCLC Stage IV, sponsored by Shandong Provincial Hospital. Status unknown at 13 sites in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-11-02.

Sponsored by Shandong Provincial Hospital · Phase 2, Interventional, and Other

The sponsor has not verified this record recently (last verified Oct 2020), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • NSCLC Stage IV

Keywords

  • NSCLC
  • Camrelizumab
  • Microwave ablation
  • Overall survival
  • Progression free survival
  • Objective response rate
  • Safety
03

In context

Lead sponsor

Shandong Provincial Hospital is the lead sponsor of 58 studies on the registry; 23 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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
  1. 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

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
05

Study design

Phase
Phase 2
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
200 participants (estimated)

Study arms

  • 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

  • Placebo comparator
    Camrelizumab group

    Patients in the group are treated with camrelizumab alone.

    Drug: Camrelizumab

Interventions

  • DrugCamrelizumab

    Patients will be treated with camrelizumab alone.

  • OtherCamrelizumab plus microwave ablation

    In the group, microwave ablation will be administrated to the primary tumors, followed by camrelizumab.

    Also known as: Camrelizumab plus MWA

06

What researchers measure

Primary outcomes

  1. Objective response rate

    ORR

    Time frame: The proportion of Patients achieved complete response or partial response up to 16 weeks

Secondary outcomes

  1. Overall survival

    OS

    Time frame: From date of randomization until the date of first documented date of death from any cause,assessed up to 24 months

  2. Progression free survival

    OS

    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

  3. Safety

    The adverse events of both microwave and camrelizumab

    Time frame: The proportion and grade of patients had adverse events up to 24 months

07

Study locations

13 of 13 sites recruiting
  • Binzhou Medical University Hospital
    Binzhou, Shandong +86 256600, China
    Recruiting
  • Dezhou People's Hospital
    Dezhou, Shandong +86 253000, China
    Recruiting
  • The Second People's Hospital of Dezhou
    Dezhou, Shandong +86 253000, China
    Recruiting
  • Jinan Military General Hospital
    Jinan, Shandong +83 250001, China
    Recruiting
  • Affliated Hospital of Shandong Academy of Medical Sciences
    Jinan, Shandong +86 250001, China
    Recruiting
  • Shandong Provincial Hospital affliated to Shandong University
    Jinan, Shandong +86053168773172, China
    Recruiting
  • Affliated Hospital of Jining Medical University
    Jining, Shandong +86 272000, China
    Recruiting
  • Liaocheng Cancer Hospital
    Liaocheng, Shandong +86 252000, China
    Recruiting
  • Affliated Hospital of Taishan Medical University
    Taian, Shandong +86 271000, China
    Recruiting
  • The People's Liberation Army 88 Hospital
    Taian, Shandong +86 271000, China
    Recruiting
  • Weifang People's Hospital
    Weifang, Shandong +86 262000, China
    Recruiting
  • Yantai Yuhuangding Hospital
    Yantai, Shandong +86 264000, China
    Recruiting
  • Tengzhou center of people's hospital
    Zaozhuang, Shandong +86 277000, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No — Principle of confidentiality

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 2, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04102982
Lead sponsor
Shandong Provincial Hospital
Responsible party
Xin Ye (Head of Section, Shandong Provincial Hospital) — Principal investigator
First posted
Sep 25, 2019
Start date
Nov 1, 2019
Primary completion
Oct 31, 2021 (estimated)
Completion
Feb 28, 2022 (estimated)
Last update
Nov 2, 2020

Study contacts

Xin Ye
Contact
yexitaian2014@163.com
+8653168773171
Zhigang Wei
Contact
weizhigang321321@163.com
+8653168773171
Xin Ye
principal investigator · Shandong Provincial Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.

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