Treatment for advanced lung squamous cell carcinoma using BAI-BACE

Bronchial Arterial Infusion Plus Bronchial Arterial Chemoembolization (BAI-BACE) for Advanced Lung Squamous Cell Carcinoma: a Multicenter Single-arm Phase II Study

This study is testing a new treatment for advanced lung cancer that directly delivers chemotherapy to the tumor to see if it helps patients who haven't responded to other therapies.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 85 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Sun Yat-sen University (other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06377735 on ClinicalTrials.gov

What this trial studies

This multicenter interventional study investigates the efficacy and safety of bronchial arterial infusion plus bronchial arterial chemoembolization (BAI-BACE) as a non-first-line therapy for advanced central squamous cell carcinoma of the lung. The approach involves directly injecting chemotherapeutic agents into the tumor to achieve high local concentrations, followed by sealing off the tumor's blood supply. This method aims to provide an alternative treatment option for patients who have failed standard therapies and are facing poor prognoses. The study will assess the survival benefits and tolerability of this treatment in a population that typically has limited options.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18-80 with centrally located squamous cell carcinoma who have failed previous treatments and have tumors limited to the chest.

Not a fit: Patients with contraindications to BAI or BACE, those under 18 or over 75 years, or those with extra-chest metastases will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new therapeutic option and improve survival rates for patients with advanced lung squamous cell carcinoma.

How similar studies have performed: Previous reports from hospitals in China have indicated that BAI-BACE may be effective, suggesting potential success for this approach.

Eligibility criteria

Inclusion Criteria:

1. Squamous cell carcinoma diagnosed by pathology, and central location by imaging;
2. Age 18-80;
3. Patients failed to the standard first-line or second-line treatment;
4. Tumors limited in the chest;
5. Tumors were fed by bronchial artery through CTA reconstruction;
6. Patents received PD-1 inhibitor or not were also included;
7. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-2;
8. Images within 2 weeks before inclusion;
9. Life expectancy more than 3 months;
10. Agreed to participated in this clinical trial;
11. Hemameba ≥3.0 x109/L, neutrophil ≥1.5x109/L, hemoglobin≥10.0 g/L, platelet≥100x 109/L, ALT; AST; bilirubin ≤1.5-fold normal, GFR≥60ml/min.

Exclusion Criteria:

1. Contraindication of BAI or BACE;
2. Under 18 years or over 75 years;
3. extra-chest metastases;
4. Receiving other antitumor treatment;
5. Severe infection or pregnancy;
6. Severe Pulmonary fibrosis and pulmonary artery;
7. liver, kidney or poor physical conditions;
8. Severe pleural effusion or pericardial effusion;
9. Life expectancy less than 3 months.

Where this trial is running

Beijing, Beijing Municipality

• Chinese PLA General hospital — Beijing, Beijing Municipality, China (RECRUITING)

Study contacts

• Principal investigator: Feng Duan, MD — Chinese PLA General Hospital
• Study coordinator: Qunfang Zhou, MD

Conditions: Squamous Cell Carcinoma, bronchial arterial infusion, bronchial arterial chemoembolization, paclitaxel, CalliSpheres, cis-platinum, advanced central squamous cell carcinoma