Clinical trial Recruiting at 1 site Interventional Ages 18 to 80

Treatment for advanced lung squamous cell carcinoma using BAI-BACE

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

Run by Sun Yat-sen University · NCT06377735 · Data updated 2026-11-12

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

Study typeInterventional
Ages18 Years to 80 Years
SexAll
Enrollment85 (estimated)
SponsorSun Yat-sen University
Academic / other
Locations1 site (Beijing, Beijing Municipality)
StatusRecruiting
StartedMay 1, 2024
Main results expectedDecember 30, 2025
Study endsDecember 30, 2026
Registry record updatedAugust 9, 2024
Trial IDNCT06377735 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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

Who can join: the full rules

Show full inclusion / exclusion 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 it's running

  • Chinese PLA General hospital
    Beijing, Beijing Municipality, China
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.