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

NCT06453889 | Not Yet Recruiting

• 1 other identifier: KS24015
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Complete ablation rate at 12 months post-procedure

  12 months

• Local control rate at 1, 2, 3 years post-procedure

  3 years

• Progression-free survival

  3 years

• Immunological response (lymphocyte phenotypes, PD-L1 expression, cytokines)

  3 months

• Number of participants with adverse events

  1 month

Study Arms (1)

Multimode thermal therapy

EXPERIMENTAL

Percutaneous multimode thermal therapy

Device: Multimode thermal therapy

Interventions

Multimode thermal therapy DEVICE

The multimode thermal therapy procedure consists of a sequential rapid freezing, natural thawing, and radio-frequency (RF) heating of the target tumor tissue.

Multimode thermal therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years old;
• 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);
• The ECOG PS score is 0-2;
• Expected survival ≥6 months;
• Negative driver gene mutation: driver genes were defined as EGFR, ALK, ROS1, RET;
• Agree to undergo multimode thermal therapy as initial treatment after being assessed unsuitable for surgery or refusing surgery, and sign informed consent.

You may not qualify if:

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

Sponsors & Collaborators

• Shanghai Chest Hospital: lead

Study Sites (1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200030, China

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jiayuan Sun

  Shanghai Chest Hospital

  STUDY DIRECTOR

Central Study Contacts

Jiayuan Sun

CONTACT

+86-021-22200000; jysun1976@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Department of Respiratory Endoscopy

Model Details: multimode thermal therapy

Study Record Dates

• First Submitted: May 25, 2024
• First Posted: June 12, 2024
• Study Start: June 5, 2024
• Primary Completion: June 5, 2025
• Study Completion (Estimated): June 5, 2027
• Last Updated: June 12, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)