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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Lung Adenocarcinoma; Local Cryoablation

• Study Type: Observational
• Enrollment (Estimated): 10

Contacts and Locations

• Study Contact: Name: Mingming Deng, MD; Phone Number: 86 18801336854; Email: isdeng1017@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with lung adenocarcinoma who have indictions of local cryoablation without any other contraindications.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
LUAD patients undergoing cryoablation; No interventions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cryoablation completion	patients complete local cryoablation	1 month

Collaborators and Investigators

• Sponsor: China-Japan Friendship Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: October 24, 2023
• First Submitted That Met QC Criteria: October 24, 2023
• First Posted (Actual): October 27, 2023

Study Record Updates

• Last Update Posted (Actual): October 27, 2023
• Last Update Submitted That Met QC Criteria: October 24, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Lung Adenocarcinoma; metabolic changes; local cryoablation; immune landscape
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Adenocarcinoma; Adenocarcinoma of Lung
• Other Study ID Numbers: ZRJY2021-BJ08-02-06

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No