Carcinoma, Non-Small Cell Lung
Conditions
Brief 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.
Interventions
PROCEDUREBAI combine with DEB-BACE
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.
Sponsors
Gang Wu
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PFS | up to 3 years | PFS was defined as the time from recruitment to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ORR | up to 3 years | ORR is defined as the percentages of patients, relative to the total of enrolled subjects, achieving a complete (CR) or partial (PR) response, according to RECIST 1.1 criteria |
| Overall survival (OS) | up to 3 years | The time from recruitment to death due to any cause. |
Countries
China
Contacts
Primary ContactGang Wu, M.D
Outcome results
None listed