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Efficiency and Safety of Microwave Ablation Plus Immune Checkpoint Inhibitor for Patients With Multiple Primary Lung Cancer: A Open, Multi-center, Phase II Clinical Trial
Led by Shanghai Pulmonary Hospital, Shanghai, China · Updated on 2021-09-23
146
Participants Needed
6
Research Sites
340 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Prospective, multi-center, phase II clinical trial. The study plans to enroll 146 patients with multiple lung cancers. After signing the informed consent, they were screened to meet the admission and discharge criteria, and received microwave ablation treatment. Electromagnetic navigation bronchoscope-guided intrapulmonary microwave ablation or percutaneous microwave ablation was selected according to the patient's wishes and the evaluation of the surgeon. After the operation, they were randomized and the experimental group accepted PD-1 immune checkpoint inhibitor treatment (microwave ablation combined with Camrelizumab treatment does not exceed 16 cycles, or disease progression/worsening or confirmed imaging disease progression, or withdrawal for any reason), the control group does not After receiving any treatment, the two groups were followed up closely (36 months after the last treatment, including safety follow-up and survival follow-up).
CONDITIONS
Official Title
Efficiency and Safety of Microwave Ablation Plus Immune Checkpoint Inhibitor for Patients With Multiple Primary Lung Cancer: A Open, Multi-center, Phase II Clinical Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 79 years
- Diagnosed with multiple pulmonary nodules by CT, with 2 to 5 target lesions distributed in at least two lung lobes
- At least one target lesion pathologically confirmed as lung cancer
- No lymph node, lung, or distant organ metastasis (N0, M0)
- ECOG performance status score between 0 and 2
- Expected survival time of at least 12 months
- Adequate blood cell counts and no recent blood transfusions or stimulating factor treatments
- Liver function with bilirubin and enzyme levels within defined limits
- Kidney function with creatinine clearance of at least 50 ml/min
- Adequate coagulation function with INR/PT within acceptable range
- Negative pregnancy test for women of childbearing age before first treatment
- Use of effective contraception for patients at risk of conception during and for 180 days after treatment
- Ability to voluntarily consent and comply with study requirements
You will not qualify if you...
- Positive genetic tests for EGFR, ALK, ROS1 fusion, BRAF V600E mutation, or NTRK fusion
- Pulmonary nodules larger than 30 mm in diameter
- Positive lymph nodes detected before surgery or biopsy
- Presence of distant metastasis, chest fluid, or ascites detected before surgery
- Participation in other clinical trials or treatments with investigational drugs/devices within 3 months
- Previous systemic anti-tumor treatments or major surgery within 3 weeks before the first intervention
- Previous treatment with PD-1, PD-L1, PD-L2 inhibitors or related immune therapies
- Conditions that affect surgery or ablation such as coagulation disorders or immune diseases
- Abnormal coagulation or bleeding tendencies, or use of thrombolytic/anticoagulant therapy
- Recent significant bleeding events within 4 weeks before treatment
- Known infections including HIV, syphilis, active tuberculosis, or untreated hepatitis
- Severe heart, liver, or kidney impairment beyond defined limits
- Mental illness or substance abuse affecting study compliance
- Other malignant tumors or blood diseases
- Pregnancy, planned pregnancy, or breastfeeding
- Any other condition the investigator judges unsuitable for participation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 6 locations
1
Changhai Hospital
Shanghai, Shanghai Municipality, China, 200433
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2
Shanghai First People's Hospital
Shanghai, Shanghai Municipality, China, 200433
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3
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China, 200433
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4
Ruijin Hospital
Shanghai, Shanghai Municipality, China
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5
Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, China
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6
Renji Hospital
Shanghai, Shangh, China
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Research Team
C
Chang Chen, Dr
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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