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A single arm, multicenter phase II study on the efficacy and safety of docetaxel intravenous chemotherapy combined with bronchial artery embolization in advanced squamous non-small cell lung cancer patients with first-line chemotherapy progression

A single arm, multicenter phase II study on the efficacy and safety of docetaxel intravenous chemotherapy combined with bronchial artery embolization in advanced squamous non-small cell lung cancer patients with first-line chemotherapy progression

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500105752
Enrollment
Unknown
Registered
2025-07-10
Start date
2025-08-29
Completion date
Unknown
Last updated
2025-07-14

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

Conditions

Advanced Squamous Non-Small Cell Lung Cancer Progressing after First-Line Chemotherapy

Interventions

Test group:Intravenous Docetaxel Chemotherapy Combined with Bronchial Artery Embolization

Sponsors

Lishui Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Patients voluntarily participate and sign informed consent. 2. Aged >=18 years, regardless of gender. 3. ECOG Performance Status score: 0-2; 4. Histologically or cytologically confirmed locally advanced and/or metastatic lung squamous cell carcinoma (LSCC); Diagnosed as stage IIIB, IIIC, or IV according to the 2023 UICC Lung Cancer Staging System (9th edition). 5. Target lesions meeting Recist 1.1 criteria: Diameter >=20 mm for non-nodal lesions, OR Short-axis diameter >=15 mm for lymph nodes. 6. Contrast-enhanced CT angiography (CTA) demonstrating tumor-feeding bronchial arteries or other systemic arteries. 7. Organ Function Requirements (within 7 days pre-treatment): a) Hematological Parameters (no transfusion within 14 days): Hemoglobin (Hb) >=9 g/dL Absolute Neutrophil Count (ANC) >=1.5×10?/L Platelets (PLT) >=90×10?/L; b) Biochemical Parameters: Total Bilirubin (TBIL) =60 mL/min; c) Cardiac Function: Left Ventricular Ejection Fraction (LVEF) >=50% (lower limit of normal) by Doppler ultrasound. 8. Women of childbearing potential: Must use contraception (e.g., IUD, oral contraceptives, condoms) during and for 6 months post-study; Negative serum/urine pregnancy test within 7 days before enrollment; Non-lactating. Male patients: Must use contraception during and for 6 months post-study.

Exclusion criteria

Exclusion criteria: 1.Patients with lung adenocarcinoma or small cell lung carcinoma (including combined small cell and non-small cell lung carcinoma); 2.Previous bronchial artery chemoembolization (BACE) or bronchial artery embolization (BAE) therapy; Prior docetaxel-based chemotherapy. 3.Other active malignancies requiring simultaneous treatment. 4.Treatment-related adverse reactions (excluding alopecia) from prior systemic anticancer therapy not recovered to Grade =1 per NCI-CTCAE v5.0; 5.Contraindications to BAE or chemotherapy. 6.Current participation in other clinical studies or =2×10³ copies/mL; HCV: HCV RNA-positive AND abnormal liver function; HBV/HCV co-infection; Active tuberculosis. 8.Any condition that may lead to premature study termination per investigator's judgment, including: Severe comorbid diseases; Clinically significant laboratory abnormalities; Social/familial factors compromising subject safety.

Design outcomes

Primary

MeasureTime frame
Objective Response Rate;

Secondary

MeasureTime frame
Disease Control Rate?Duration of Overall Response;Tumor markers;Progression Free Survival;Overall Survival;ECOG Performance Status score;

Countries

China

Contacts

Public ContactJiansong Ji

Lishui Central Hospital

jjstcty@sina.com+86 13857088508

Outcome results

None listed

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