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Trial Title:
Efficacy and Safety of Multimode Thermal Therapy in the Treatment of Early Peripheral Lung Cancer
NCT ID:
NCT06453889
Condition:
Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
multimode thermal therapy
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
Multimode thermal therapy
Description:
The multimode thermal therapy procedure consists of a sequential rapid freezing, natural
thawing, and radio-frequency (RF) heating of the target tumor tissue.
Arm group label:
Multimode thermal therapy
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Shanghai Chest Hospital
Address:
City:
Shanghai
Zip:
200030
Country:
China
Contact:
Last name:
Jiayuan Sun
Phone:
+86-021-22200000
Phone ext:
1511
Email:
jysun1976@163.com
Start date:
June 5, 2024
Completion date:
June 5, 2027
Lead sponsor:
Agency:
Shanghai Chest Hospital
Agency class:
Other
Source:
Shanghai Chest Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06453889
