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Trial Title:
Local and Peripheral Immune Responsive Landscape Induced by Local Cryoablation in Patients With Lung Adenocarcinoma
NCT ID:
NCT06104709
Condition:
Lung Adenocarcinoma
Local Cryoablation
Conditions: Official terms:
Adenocarcinoma
Adenocarcinoma of Lung
Conditions: Keywords:
Lung Adenocarcinoma
local cryoablation
immune landscape
metabolic changes
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Prospective
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 answer are:
- local and peripheral immune changes in patients with lung adenocarcinoma undergoing
cryoablation.
- local and peripheral metabolic changes in patients with lung adenocarcinoma
undergoing cryoablation.
Peripheral blood, biopsy tissues of patients will be collected at the baseline and after
cryoablation. Single-cell sequencing, single-cell immune bank, metabolomics and spatial
metabolomics will be used to explore the local and peripheral immune changes and
metabolites changes in patients with lung adenocarcinoma before and after cryoablation.
Criteria for eligibility:
Study pop:
Patients with lung adenocarcinoma who have indictions of local cryoablation without any
other contraindications.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
1. Primary or metastatic lung cancer with definite pathological diagnosis.
2. Patients are not suitable for thoracotomy due to serious lung or systemic disease.
3. Peripheral lung cancer involves pleura and chest wall, which cannot be completely
removed by surgical resection.
4. There are indications for surgical resection, but the patient refuses surgery.
5. Single tumor, maximum diameter ≤5cm; Or the number of tumors ≤3, the maximum
diameter ≤3cm.
6. ECOG-PS score≤2.
7. Patients with an expected survival of more than three months.
8. Patients have not participated in other clinical validation within 3 months.
9. Subjects voluntarily sign informed consent.
Exclusion Criteria:
1. Serious heart and brain disease or other mental illness.
2. Severe pulmonary fibrosis, especially drug-induced pulmonary fibrosis.
3. Patients with previous severe pulmonary dysfunction, pulmonary ventilation disorder,
and multiple pulmonary bulla.
4. A history of immunodeficiency, including a positive HIV test (enzyme-linked
immunoassay and Western spot assay).
5. Patients treated with chemotherapy, radiotherapy, interventional therapy, ablative
therapy or surgery within 30 days before surgical treatment.
6. There is a serious bleeding tendency, platelets less than 50×109 /L and coagulation
function is seriously disturbed.
7. Coagulation index (PT, TT, APTT) > 2.5 times the upper limit of normal.
8. Ablation of ipsilateral malignant pleural effusion is not well controlled.
9. Poor general condition, multiple organ failure, cachexia, severe anemia and
nutritional metabolism disorders.
10. Patients with extensive extrapulmonary metastasis are not suitable for ablative
therapy.
11. People who regularly use sedatives, sleeping pills, tranquilizers or other addictive
drugs.
12. Pregnant or breastfeeding women.
13. Patients who cannot evaluate the efficacy.
14. 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
90 Years
Healthy volunteers:
No
Start date:
December 1, 2023
Completion date:
December 31, 2024
Lead sponsor:
Agency:
China-Japan Friendship Hospital
Agency class:
Other
Source:
China-Japan Friendship Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06104709
