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Trial Title:
Efficacy and Safety of BAI Combined With DEB-BACE of EqualSpheres in the Treatment of Advanced NSCLC
NCT ID:
NCT06127329
Condition:
Carcinoma, Non-Small Cell Lung
Conditions: Official terms:
Carcinoma, Non-Small-Cell Lung
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
BAI combine with DEB-BACE
Description:
1. First treatment. Only infusion chemotherapy (THP + Platinum + Letitrexed), THP 20
~30mg/m2, Nedaplatin 40mg/m2, Letitrexed 3mg/m2.
2. Second treatment. After infusionchemotherapy, EqualSpheres microsphere used for
embolization: EqualSpheres microspheres (400 μm) 1tube was loaded and adsorbed THP
(40 ~ 60mg/m2). End point of embolization: stagnation of blood flow in tumor feeding
artery.
Arm group label:
BAI combine with DEB-BACE
Summary:
This is a prospective, single-arm, open-label study designed to evaluate the efficacy and
safety of bronchial infusion chemotherapy（BAI） combined with drug-loaded microsphere
embolization of EqualSpheres in advanced Non-small cell lung cancer (NSCLC).
Progression-free survival (PFS) will be evaluated as the primary endpoint.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age > 18 years old, male and female;
2. According to the Guidelines for the Diagnosis and Treatment of Primary Lung Cancer
(2022 edition), the patient was diagnosed with NSCLC by imaging and histopathology;
3. TNM stages were III-IV;
4. Newly diagnosed, first-line treatment failure, refusal or inability to perform
conventional treatment (surgery, chemoradiotherapy);
5. ECOG PS ≤2;
6. Expected survival > 3 months;
7. Sign the informed consent voluntarily, and the compliance is good.
Exclusion Criteria:
1. Previously received interventional therapy (iodine particle implantation, ablation,
TACE treatment);
2. Combined with extensive and uncontrolled extrapulmonary metastases, such as liver
metastasis, bone metastasis, and brain metastasis;
3. Have had or currently having other primary malignant tumors;
4. White blood cell < 3×109/L, platelet count < 50×109/L, HGB < 90 g/L;
5. Hepatic and renal insufficiency (creatinine > 2 mg/L; AST and/or ALT > 2 times the
normal upper limit);
6. Coagulation dysfunction (INR > 1.5) or known bleeding disease (except lung cancer
combined with hemoptysis), or anticoagulation therapy;
7. Patients with active infection requiring antibiotic treatment;
8. Uncontrolled hypertension, diabetes, and cardiovascular disease with obvious
symptoms;
9. contrast agent allergy;
10. Women with pregnancy or lactation.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Gang Wu
Address:
City:
Zhengzhou
Country:
China
Contact:
Last name:
Gang Wu, M.D
Phone:
+8613938570175
Email:
wuganghenan2015@163.com
Start date:
December 1, 2023
Completion date:
December 1, 2026
Lead sponsor:
Agency:
Gang Wu
Agency class:
Other
Source:
The First Affiliated Hospital of Zhengzhou University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06127329
