ClinicalTrials.gg
Status unknownNCT06104709Updated Oct 27, 2023

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

An observational study in Lung Adenocarcinoma and Local Cryoablation, sponsored by China-Japan Friendship Hospital. Status unknown. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2023-10-27.

Sponsored by China-Japan Friendship Hospital · Observational

The sponsor has not verified this record recently (last verified Oct 2023), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
10
Ages
18 Years to 90 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Lung Adenocarcinoma
  • Local Cryoablation

Keywords

  • Lung Adenocarcinoma
  • local cryoablation
  • immune landscape
  • metabolic changes
03

In context

Adenocarcinoma of Lung

315 studies on the registry are indexed under Adenocarcinoma of Lung; 83 are open to participants now.

This study's planned enrollment of 10 is below the median of 201 across 84 observational studies indexed under Adenocarcinoma of Lung.

Browse Adenocarcinoma of Lung studies →

Lead sponsor

China-Japan Friendship Hospital is the lead sponsor of 177 studies on the registry; 110 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
10 participants (estimated)
Patient registry
No

Groups and cohorts

  • LUAD patients undergoing cryoablation

    No interventions.

06

What researchers measure

Primary outcomes

  1. cryoablation completion

    patients complete local cryoablation

    Time frame: 1 month

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 27, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06104709
Responsible party
Gang Hou (Principle Investigator, China-Japan Friendship Hospital) — Principal investigator
First posted
Oct 27, 2023
Start date
Dec 1, 2023 (estimated)
Primary completion
Dec 31, 2024 (estimated)
Completion
Dec 31, 2024 (estimated)
Last update
Oct 27, 2023

Study contacts

Mingming Deng, MD
Contact
isdeng1017@163.com
86 18801336854

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.

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