Status:
UNKNOWN
Drug-eluting Beads Bronchial Arterial Chemoembolization in Stage II-III Non-small-cell Lung Cancer Patients Failed, Refused or Ineligible to Receive Standard Treatments
Lead Sponsor:
Tianjin Medical University Cancer Institute and Hospital
Conditions:
Carcinoma, Non-Small-Cell Lung
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This is a multicenter, prospective, single-arm clinical study to determine the efficacy and safety of Drug-eluting beads bronchial arterial chemoembolization（DEB-BACE） in stage II-III NSCLC patients w...
Eligibility Criteria
Inclusion
- Patients ≥ 18 years old, of any sex;
- Patients who have histopathological proof of NSCLC according to the standard of diagnosis and treatment of primary lung cancer（V2018）;
- Confirmed TNM stage is II-III of NSCLC;
- Patients who were failed, refused or assessed ineligible by MDT to receive conventional Second-Line treatments (surgery, chemoradiotherapy, targeted and immunotherapy)；
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0-2;
- Life expectancy of \> 3 months;
- Patients volunteered to participate in this study and signed informed consent, with good compliance;
Exclusion
- Patients received interventional therapy (I seeds implantation, Ablation, BACE) before;
- A history combined with other malignant tumors and not cured;
- WBC\<3×109/L、LYM\<1.5×109/L、NLR≥3、PLT\<50×109/L、HGB\<90 g/L;
- Insufficient of liver and renal function (Cr\>176.8 µmol/L; AST and/or ALT\>2 folds of normal value)；
- Combined with uncorrectable coagulation dysfunction or active massive hemoptysis;
- Combined with active affection and need antibiotic treatment;
- Uncontrollable hypertension, diabetes, cardiovascular disease with obvious symptoms;
- Known to be hypersensitive to contrast agent;
- Pregnant or breastfeeding women;
Key Trial Info
Start Date :
May 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2024
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04825925
Start Date
May 1 2021
End Date
October 1 2024
Last Update
April 12 2021
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