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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Lung Cancer
• Intervention / Treatment: Device: 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 Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jiayuan Sun; Phone Number: 1511 +86-021-22200000; Email: jysun1976@163.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200030
      • Shanghai Chest Hospital
      • Contact: Jiayuan Sun; Phone Number: 1511 +86-021-22200000; Email: jysun1976@163.com

Participation Criteria

Eligibility Criteria

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

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Multimode thermal therapy; Percutaneous multimode thermal therapy	Device: Multimode thermal therapy; The multimode thermal therapy procedure consists of a sequential rapid freezing, natural thawing, and radio-frequency (RF) heating of the target tumor tissue.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete ablation rate at 12 months post-procedure	This refers to the proportion of completely ablated lesions in the total ablated lesions at 12 months after multimode thermal therapy.	12 months
Local control rate at 1, 2, 3 years post-procedure	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.	3 years
Progression-free survival	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.	3 years
Immunological response (lymphocyte phenotypes, PD-L1 expression, cytokines)	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.	3 months
Number of participants with adverse events	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.	1 month

Collaborators and Investigators

• Sponsor: Shanghai Chest Hospital
• Investigators: Study Director: Jiayuan Sun, Shanghai Chest Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): June 5, 2024
• Primary Completion (Estimated): June 5, 2025
• Study Completion (Estimated): June 5, 2027

Study Registration Dates

• First Submitted: May 25, 2024
• First Submitted That Met QC Criteria: June 5, 2024
• First Posted (Actual): June 12, 2024

Study Record Updates

• Last Update Posted (Actual): June 12, 2024
• Last Update Submitted That Met QC Criteria: June 5, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: KS24015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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