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NCT06377735Recruiting

BAI-BACE for Advanced Lung Squamous Cell Carcinoma

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

Source: ClinicalTrials.gov · Last updated 9 Aug 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

Bronchial arterial infusion plus bronchial arterial chemoembolization (BAI-BACE) has been reported as non-first-line therapy to treat lung cancer in many hospitals in China. BAI, which uses chemotherapeutic drugs directly injected into the tumor and achieved a high concentration in a short time to kill the tumor. Then BACE could seal off the tumor vessels. In this study, we aim to describe the efficacy and safety of BAI-BACE as non-first-line for advanced lung squamous cell carcinoma.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
85 (estimated)
First submitted
17 Apr 2024
Start date
1 May 2024
Primary completion date
30 Dec 2025
Lead sponsor
Sun Yat-sen University
Diseases
Lung cancer
NCT number
NCT06377735

What you commit to

  • Study type: Interventional
  • Planned participants: 85
  • From 1 May 2024 to the primary completion date, 30 Dec 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Receiving other antitumor treatment;

Other illness

  • Severe infection or pregnancy;
  • liver, kidney or poor physical conditions;

Other

  • Contraindication of BAI or BACE;
  • Under 18 years or over 75 years;
  • extra-chest metastases;
  • Severe Pulmonary fibrosis and pulmonary artery;
  • Severe pleural effusion or pericardial effusion;
  • Life expectancy less than 3 months.

Who the study is looking for

  • Squamous cell carcinoma diagnosed by pathology, and central location by imaging;
  • Age 18-80;
  • Patients failed to the standard first-line or second-line treatment;
  • Tumors limited in the chest;
  • Tumors were fed by bronchial artery through CTA reconstruction;
  • Patents received PD-1 inhibitor or not were also included;
  • Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-2;
  • Images within 2 weeks before inclusion;
  • Life expectancy more than 3 months;
  • Agreed to participated in this clinical trial;
  • 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.

Age in the registry: 18 years to 80 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Chinese PLA General Hospital
Coordinator of this site? Confirm its status
BeijingChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.