Efficacy and Safety of Multimode Thermal Therapy in the Treatment of Early Peripheral Lung Cancer

Not Applicable

Not yet recruiting

• Conditions: Lung Cancer
• Interventions: Device: Multimode thermal therapy

• Registration Number: NCT06453889
• Lead Sponsor: Shanghai Chest Hospital

Brief Summary

The purpose of the study is to evaluate the efficacy and safety of multimode thermal therapy for early peripheral lung cancer, and to explore the changes of systemic immune microenvironment after multimode thermal therapy.

Detailed Description

This is a single-center, single-arm, exploratory study, and is expected to enroll a total of 10 patients. The enrolled patients were stage IA lung cancer patients with lung lesions found on chest CT, pathologically diagnosed as non-small cell lung cancer, negative for driver gene mutations, and who were considered high-risk or refused surgery by multidisciplinary evaluation. Follow-ups are performed after the multimode thermal therapy. The primary endpoint is complete ablation rate at 6 months after multimode thermal therapy. The secondary endpoints are complete ablation rate at 12 months after multimode thermal therapy, local control rate at 1, 2, 3 years post-procedure, progression-free survival and mmune effects after multimodal thermal therapy.

Study Timeline

• Study First Submitted: 2024-05-25
• Status Verified: 2024-06
• Study Start: 2024-06-05
• Study First Submitted QC: 2024-06-05
• Last Update Submitted: 2024-06-05
• Study First Posted: 2024-06-12
• Last Update Posted: 2024-06-12
• Primary Completion: 2025-06-05
• Study Completion: 2027-06-05

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

1. Age ≥18 years old;
2. Pathologically diagnosed as primary peripheral non-small cell lung cancer, preoperative staging suggested clinical staging as T1N0M0, stage IA (including new-onset lung cancer after surgery and multiple primary lung cancer);
3. The ECOG PS score is 0-2;
4. Expected survival ≥6 months;
5. Negative driver gene mutation: driver genes were defined as EGFR, ALK, ROS1, RET;
6. Agree to undergo multimode thermal therapy as initial treatment after being assessed unsuitable for surgery or refusing surgery, and sign informed consent.

Exclusion Criteria

1. Patients with poor cardiopulmonary function or other comorbidities who cannot tolerate multimode thermal therapy;
2. Patients whose chest CT indicated that the lung lesions could not be reached through the chest wall through multimode thermal therapy;
3. Severe liver and kidney function and coagulation function abnormalities, platelet count <70×109/L;
4. Poor control of malignant pleural effusion;
5. Patients who have received other anti-tumor drugs or have used immune checkpoint inhibitors in the past 6 months;
6. The patient has an uncontrolled disease (including but not limited to active infection, symptomatic congestive heart failure, unstable angina, arrhythmia, mental illness, etc.);
7. Those who have undergone surgical operations or had allogeneic organ transplants within 1 month;
8. Primary immune deficiency or autoimmune diseases (e.g. rheumatoid arthritis, systemic lupus erythematosus, etc.);
9. Pregnant and lactating women;
10. Long-term use of steroid;
11. Other circumstances considered inappropriate for participation in this study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Multimode thermal therapy	Multimode thermal therapy	Percutaneous multimode thermal therapy

Primary Outcome Measures

Name	Time	Method
Complete ablation rate at 6 months post-procedure	6 months	This refers to the proportion of completely ablated lesions in the total ablated lesions at 6 months after multimode thermal therapy.

Secondary Outcome Measures

Name	Time	Method
Immunological response (lymphocyte phenotypes, PD-L1 expression, cytokines)	3 months	This refers to the changes from baseline in the immunological responses following the multimode thermal therapy, including the percentage and function of lymphocyte phenotypes, the expression of PD-L1, the concentration of IL-6/IL-17A levels, etc.
Local control rate at 1, 2, 3 years post-procedure	3 years	This refers to the proportion of completely and incompletely ablated lesions in the total ablated lesions at 1 year, 2 years and 3 years after multimode thermal therapy.
Progression-free survival	3 years	This refers to the length of time between the participant's first onset of disease progression or death from any cause after multimode thermal therapy.
Number of participants with adverse events	1 month	This refers to all treatment-related adverse events (grade 1- 5) occurring during the trial and follow-up period as assessed by CTCAE v5.0.
Complete ablation rate at 12 months post-procedure	12 months	This refers to the proportion of completely ablated lesions in the total ablated lesions at 12 months after multimode thermal therapy.

Trial Locations

Locations (1)

Shanghai Chest Hospital; 🇨🇳 Shanghai, Shanghai, China