Local and Peripheral Immune Responsive Landscape Induced by Local Cryoablation in Patients With Lung Adenocarcinoma

Lung Adenocarcinoma Clinical Trial

Official title:

Local and Peripheral Immune Responsive Landscape Induced by Local Cryoablation in Patients With Lung Adenocarcinoma

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06104709
• Other study ID #: ZRJY2021-BJ08-02-06
• Status: Not yet recruiting
• Start date: December 1, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: October 2023
• Source: China-Japan Friendship Hospital
• Contact: Mingming Deng, MD
• Phone: 86 18801336854
• Email: isdeng1017[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of Lung
• Lung Adenocarcinoma

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
China-Japan Friendship Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cryoablation completion	patients complete local cryoablation	1 month