Status:
NOT_YET_RECRUITING
Efficacy and Safety of DEB-BACE Combined With PD-1 Inhibitors in Stage II/III NSCLC With Standard Treatment Failure
Lead Sponsor:
The Central Hospital of Lishui City
Collaborating Sponsors:
Jiangxi Provincial Cancer Hospital
Jiangxi Chest Hospital
Conditions:
Carcinoma, Non-Small-Cell Lung
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study is a prospective, multi-center, randomized, open-ended, double-arm clinical study. All eligible patients were randomly assigned to DEB-BACE combined with PD-1 inhibitor (Sindilizumab) treat...
Eligibility Criteria
Inclusion
- Age more than 18 years old, no gender limit.
- According to the Diagnosis and Treatment of Primary Lung Cancer (2018 edition), non-small cell lung cancer (NSCLC) was diagnosed by histopathology.
- Tumor Node Metastasis (TNM) staging is II-III.
- According to the National Comprehensive Cancer Network (NCCN) guidelines, patients who had failed, refused, or were not suitable for standard treatment (surgery, chemoradiotherapy, targeted) after consultation.
- Eastern Cooperative Oncology Group (ECOG), Performance Status (PS) Score ≤ 2.
- Estimated survival time is more than 3 months.
- The patient has signed informed consent.
Exclusion
- The patient has previously received interventional therapy \[iodine seed implantation, ablation, bronchial arterial chemoembolization (BACE) therapy\], or received immunotherapy during the first-line standard treatment.
- The patient is accompanied by other malignant tumors and had not been cured.
- White blood cell \< 3×10\*9/L, absolute value of neutrophils \< 1.5×10\*9/L, neutrophil/lymphocyte ratio ≥ 3, platelet count \< 50×10\*9/L, hemoglobin concentration \< 90 g/L.
- Liver and kidney dysfunction (creatinine \> 176.8 μmol/L; aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \> 2 times the upper limit of normal).
- Uncorrectable coagulopathy or active hemoptysis.
- Patient with active infections requires antibiotic treatment.
- Patient has uncontrollable hypertension, diabetes, and cardiovascular disease with obvious symptoms.
- Allergy to contrast agents.
- Women with pregnancy or lactation.
Key Trial Info
Start Date :
February 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
98 Patients enrolled
Trial Details
Trial ID
NCT05248022
Start Date
February 1 2024
End Date
December 31 2024
Last Update
January 9 2024
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