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

Overview

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.

Interventions

• 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.

Primary outcome measures

• Complete ablation rate at 6 months post-procedure [Time frame: 6 months]

Secondary outcome measures (5)

• Complete ablation rate at 12 months post-procedure [Time frame: 12 months]
• Local control rate at 1, 2, 3 years post-procedure [Time frame: 3 years]
• Progression-free survival [Time frame: 3 years]
• Immunological response (lymphocyte phenotypes, PD-L1 expression, cytokines) [Time frame: 3 months]
• Number of participants with adverse events [Time frame: 1 month]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• Shanghai Chest Hospital — Shanghai

Identifiers

NCT: NCT06453889 · KS24015

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗