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Interventional study of DC BeadTM epirubicin in the treatment of unreactable lung squamous cell carcinoma

Interventional study on the treatment of unresectable lung squamous cell carcinoma by transcatheter embolization of bronchial artery by DC BeadTM

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000033037
Enrollment
Unknown
Registered
2020-05-18
Start date
2020-06-01
Completion date
Unknown
Last updated
2020-10-13

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

Conditions

Squamous cell lung carcinoma

Interventions

Group A:D-BACE +chemotherapy
Stage II:DEB-BACE +chemotherapy

Sponsors

Guangdong Provincial People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: The patients should meet all the following criteria before participating in the trial: 1. 18 years old = 3 months; 4. The physical condition (PS) score of ECoG was less than 2; 5. Laboratory examination: leukocyte >= 3.5 x 10^9 / L, platelet count >= 50 x 10^9 / L, hemoglobin >= 85g / L, lymphocyte count >= 15%, total bilirubin <= 100mmol / L, ALT and AST not more than 5 times of the normal value, serum creatinine not more than 1.5 times of the normal value; coagulation function within the normal range; 6. There was no contraindication of intravascular interventional therapy; 7. The pregnancy test of women of childbearing age must be negative; or the male and female patients need to agree to use effective contraceptive measures during the treatment period and the following one year; 8. The patient signs the informed consent and can comply with the requirements of the scheme. If the patient cannot sign the informed consent, it needs to be signed by his legal guardian or agent.

Exclusion criteria

Exclusion criteria: Subjects meeting any of the following criteria were excluded from the study: 1. Patients with advanced, metastatic or recurrent squamous cell carcinoma of the lung who have received or received chemotherapy; 2. Patients with other extrapulmonary metastasis; 3. Patients with clinically serious cardiovascular diseases, such as cerebrovascular accident (within 6 months before enrollment), myocardial infarction (within 6 months before enrollment), uncontrolled hypertension, unstable angina, congestive heart failure (nyha2-4 grade); 4. Patients with severe infection or diabetes; 5. Patients with primary malignant tumor with other organs (within five years); 6. DSA showed that the tumor artery contained anterior spinal artery and / or esophageal artery and could not be avoided; the bronchial artery was too thin and failed to be intubated; the arteriovenous fistula of bronchus which could not be embolized by microsphere was predicted; 7. Patients who are severely allergic to any of the drugs in the study; 8. Complications or social environment that can cause subjects to fail to follow the research plan or even endanger the safety of patients.

Design outcomes

Primary

MeasureTime frame
ORR;DCR;

Secondary

MeasureTime frame
PFS;OS;

Countries

China

Contacts

Public ContactXu Rongde

Guangdong Provincial People's Hospital

13922754606@139.com+86 13922754606

Outcome results

None listed

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