Status:
NOT_YET_RECRUITING
Efficacy and Safety of BAI Combined With DEB-BACE of EqualSpheres in the Treatment of Advanced NSCLC
Lead Sponsor:
Gang Wu
Conditions:
Carcinoma, Non-Small Cell Lung
Eligibility:
All Genders
18+ years
Phase:
NA
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 EqualSphe...
Eligibility Criteria
Inclusion
- Age \> 18 years old, male and female;
- 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;
- TNM stages were III-IV;
- Newly diagnosed, first-line treatment failure, refusal or inability to perform conventional treatment (surgery, chemoradiotherapy);
- ECOG PS ≤2;
- Expected survival \> 3 months;
- Sign the informed consent voluntarily, and the compliance is good.
Exclusion
- Previously received interventional therapy (iodine particle implantation, ablation, TACE treatment);
- Combined with extensive and uncontrolled extrapulmonary metastases, such as liver metastasis, bone metastasis, and brain metastasis;
- Have had or currently having other primary malignant tumors;
- White blood cell \< 3×109/L, platelet count \< 50×109/L, HGB \< 90 g/L;
- Hepatic and renal insufficiency (creatinine \> 2 mg/L; AST and/or ALT \> 2 times the normal upper limit);
- Coagulation dysfunction (INR \> 1.5) or known bleeding disease (except lung cancer combined with hemoptysis), or anticoagulation therapy;
- Patients with active infection requiring antibiotic treatment;
- Uncontrolled hypertension, diabetes, and cardiovascular disease with obvious symptoms;
- contrast agent allergy;
- Women with pregnancy or lactation.
Key Trial Info
Start Date :
December 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT06127329
Start Date
December 1 2023
End Date
December 1 2026
Last Update
November 13 2023
Active Locations (1)
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1
Gang Wu
Zhengzhou, Henan, China