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

NSCLC Stage IV Clinical Trial

— MWA in NSCLC  

Official title:

Shandong Provincial Hospital Affiliated to Shandong University

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04102982
• Other study ID #: Shandong PH
• Status: Recruiting
• Phase: Phase 2
• Start date: November 1, 2019
• Est. completion date: February 28, 2022

Study information

• Verified date: October 2020
• Source: Shandong Provincial Hospital
• Contact: Xin Ye
• Phone: +8653168773171
• Email: yexitaian2014[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: February 28, 2022
• Est. primary completion date: October 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• NSCLC Stage IV

Intervention

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.

Locations

Country	Name	City	State
China	Binzhou Medical University Hospital	Binzhou	Shandong
China	Dezhou People's Hospital	Dezhou	Shandong
China	The Second People's Hospital of Dezhou	Dezhou	Shandong
China	Affliated Hospital of Shandong Academy of Medical Sciences	Jinan	Shandong
China	Jinan Military General Hospital	Jinan	Shandong
China	Shandong Provincial Hospital affliated to Shandong University	Jinan	Shandong
China	Affliated Hospital of Jining Medical University	Jining	Shandong
China	Liaocheng Cancer Hospital	Liaocheng	Shandong
China	Affliated Hospital of Taishan Medical University	Taian	Shandong
China	The People's Liberation Army 88 Hospital	Taian	Shandong
China	Weifang People's Hospital	Weifang	Shandong
China	Yantai Yuhuangding Hospital	Yantai	Shandong
China	Tengzhou center of people's hospital	Zaozhuang	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Shandong Provincial Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate	ORR	The proportion of Patients achieved complete response or partial response up to 16 weeks
Secondary	Overall survival	OS	From date of randomization until the date of first documented date of death from any cause,assessed up to 24 months
Secondary	Progression free survival	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
Secondary	Safety	The adverse events of both microwave and camrelizumab	The proportion and grade of patients had adverse events up to 24 months