Clinical trial NCT06453889: Efficacy and Safety of Multimode Thermal Therapy in the Treatment of Early Peripheral Lung Cancer
Official title: Efficacy and Safety of Multimode Thermal Therapy in the Treatment of Early Peripheral Lung Cancer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Lung Cancer
Lead sponsor: Shanghai Chest Hospital
Sponsor class: OTHER
First posted: 2024-06-12
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: multimode thermal therapy
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Complete ablation rate at 6 months post-procedure
timeFrame: 6 months
Secondary outcomes:
measure: Complete ablation rate at 12 months post-procedure
timeFrame: 12 months
measure: Local control rate at 1, 2, 3 years post-procedure
timeFrame: 3 years
measure: Progression-free survival
timeFrame: 3 years
measure: Immunological response (lymphocyte phenotypes, PD-L1 expression, cytokines)
timeFrame: 3 months
measure: Number of participants with adverse events
timeFrame: 1 month
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Chest Hospital
state: Shanghai
Study officials:
affiliation: Shanghai Chest Hospital
name: Jiayuan Sun
role: STUDY_DIRECTOR
References: