Efficacy and Safety of BAI Combined With DEB-BACE of EqualSpheres in the Treatment of Advanced NSCLC
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: BAI combine with DEB-BACE.
- Who it may be relevant to
- Registry conditions: Carcinoma, Non-Small Cell Lung. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Efficacy and Safety of Bronchial Infusion Chemotherapy Combined With Drug-loaded Microsphere Embolization of EqualSpheres in the Treatment of Advanced Non-small Cell Lung Cancer
Overview
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
- Procedure BAI 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.
Primary outcome measures
- PFS [Time frame: up to 3 years]
Secondary outcome measures (2)
- ORR [Time frame: up to 3 years]
- Overall survival (OS) [Time frame: up to 3 years]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Gang Wu — Zhengzhou
Identifiers
NCT: NCT06127329 · 2023-KY-1101-001