Status:
UNKNOWN
Local and Peripheral Immune Responsive Landscape Induced by Local Cryoablation in Patients With Lung Adenocarcinoma
Lead Sponsor:
China-Japan Friendship Hospital
Conditions:
Lung Adenocarcinoma
Local Cryoablation
Eligibility:
All Genders
18-90 years
Brief Summary
The goal of this observational study is to learn about local and peripheral immune and metabolic changes in patients with lung adenocarcinoma undergoing cryoablation. The main question it aims to answ...
Eligibility Criteria
Inclusion
- Primary or metastatic lung cancer with definite pathological diagnosis.
- Patients are not suitable for thoracotomy due to serious lung or systemic disease.
- Peripheral lung cancer involves pleura and chest wall, which cannot be completely removed by surgical resection.
- There are indications for surgical resection, but the patient refuses surgery.
- Single tumor, maximum diameter ≤5cm; Or the number of tumors ≤3, the maximum diameter ≤3cm.
- ECOG-PS score≤2.
- Patients with an expected survival of more than three months.
- Patients have not participated in other clinical validation within 3 months.
- Subjects voluntarily sign informed consent.
Exclusion
- Serious heart and brain disease or other mental illness.
- Severe pulmonary fibrosis, especially drug-induced pulmonary fibrosis.
- Patients with previous severe pulmonary dysfunction, pulmonary ventilation disorder, and multiple pulmonary bulla.
- A history of immunodeficiency, including a positive HIV test (enzyme-linked immunoassay and Western spot assay).
- Patients treated with chemotherapy, radiotherapy, interventional therapy, ablative therapy or surgery within 30 days before surgical treatment.
- There is a serious bleeding tendency, platelets less than 50×109 /L and coagulation function is seriously disturbed.
- Coagulation index (PT, TT, APTT) \> 2.5 times the upper limit of normal.
- Ablation of ipsilateral malignant pleural effusion is not well controlled.
- Poor general condition, multiple organ failure, cachexia, severe anemia and nutritional metabolism disorders.
- Patients with extensive extrapulmonary metastasis are not suitable for ablative therapy.
- People who regularly use sedatives, sleeping pills, tranquilizers or other addictive drugs.
- Pregnant or breastfeeding women.
- Patients who cannot evaluate the efficacy.
- Other conditions determined by the investigators to be unsuitable for inclusion, such as inability to tolerate cryoablation surgery, difficulty in follow-up, and other serious diseases.
Key Trial Info
Start Date :
December 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06104709
Start Date
December 1 2023
End Date
December 31 2024
Last Update
October 27 2023
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