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Doxorubicin-eluting beads for end-stage non small cell lung cancer: a clinical observation study

Intra-arterial chemoembolization with doxorubicin-eluting beads for end-stage non small cell lung cancer

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1800018333
Enrollment
Unknown
Registered
2018-09-12
Start date
2018-10-01
Completion date
Unknown
Last updated
2018-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

non small cell lung cancer

Interventions

Case series:doxorubicin-eluting beads

Sponsors

The Affiliated Hospital of Hu'nan University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1) the age is above 18 years, and the sex is not limited; 2) NSCLC was diagnosed by pathological and/or cytological examination under fiberoptic bronchoscope or CT-guided puncture biopsy. Stages III and IV of international lung cancer were unresectable, systemic chemotherapy failed, gene testing (EGFR, ALK) negative or refusal / incompetence to use targeted drugs; 3) the estimated survival period is longer than 6 months; 4) the ECOG (PS) score is less than 2; 5) Laboratory examination: white blood cell (> 3 *109/L), platelet count (> 60 *109/L), hemoglobin (> 85g/L), lymphocyte count (> 15%), total bilirubin (> 100mmol/L), ALT and AST (> 5 times) and serum creatinine (> 1.5 times); 6) contraindication of non vascular interventional therapy; 7) Female pregnancy tests of reproductive age must be negative, or male and female patients must agree to use effective contraceptives during treatment and within the following year; 8) the patients signed the informed consent to participate in the trial study, and they were able to follow up and have good compliance.

Exclusion criteria

Exclusion criteria: 1) surgical tumor resection or local ablation can be performed; 2) coagulation function is poor INR > 1.5 or undergoing anticoagulation therapy or known hemorrhagic diseases; 3) unstable coronary heart disease or recent myocardial infarction (less than one year); 4) recent infections need antibiotic treatment; 5) primary malignant tumors with other organs; 6) DSA showed that the feeding artery of the tumor contained anterior spinal artery and/or esophageal artery and could not be avoided; the bronchial artery was too thin and the intubation was unsuccessful; the arteriovenous fistula could not be embolized by microspheres; 7) can cause the subjects to fail to follow the research plan or even endanger the patient's safety complications or social environment.

Design outcomes

Primary

MeasureTime frame
Objective response rate;

Secondary

MeasureTime frame
Progression free survival;1 and 2 year survival rates;Improvement of pulmonary function;Improvement of living conditions;Safety evaluation;

Countries

China

Contacts

Public ContactDeng Xiangsheng

The Affiliated Hospital of Hu'nan University of Chinese Medicine

Dengxiangsheng2009@163.com+86 13723898028

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026