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NCT06127329Not yet recruiting

Efficacy and Safety of BAI Combined With DEB-BACE of EqualSpheres in the Treatment of Advanced NSCLC

Efficacy and Safety of Bronchial Infusion Chemotherapy Combined With Drug-loaded Microsphere Embolization of EqualSpheres in the Treatment of Advanced Non-small Cell Lung Cancer

Source: ClinicalTrials.gov · Last updated 13 Nov 2023 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

This is a prospective, single-arm, open-label study designed to evaluate the efficacy and safety of bronchial infusion chemotherapy(BAI) combined with drug-loaded microsphere embolization of EqualSpheres in advanced Non-small cell lung cancer (NSCLC). Progression-free survival (PFS) will be evaluated as the primary endpoint.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
70 (estimated)
First submitted
7 Nov 2023
Start date
1 Dec 2023
Primary completion date
1 Dec 2024
Lead sponsor
Gang Wu
Diseases
Lung cancer
NCT number
NCT06127329

What you commit to

  • Study type: Interventional
  • Planned participants: 70
  • From 1 Dec 2023 to the primary completion date, 1 Dec 2024
  • 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

  • Previously received interventional therapy (iodine particle implantation, ablation, TACE treatment);

Other illness

  • Have had or currently having other primary malignant tumors;
  • Patients with active infection requiring antibiotic treatment;
  • Uncontrolled hypertension, diabetes, and cardiovascular disease with obvious symptoms;
  • contrast agent allergy;

Lab values

  • White blood cell \< 3×109/L, platelet count \< 50×109/L, HGB \< 90 g/L;
  • Hepatic and renal insufficiency (creatinine \> 2 mg/L; AST and/or ALT \> 2 times the normal upper limit);
  • Coagulation dysfunction (INR \> 1.5) or known bleeding disease (except lung cancer combined with hemoptysis), or anticoagulation therapy;

Other

  • Combined with extensive and uncontrolled extrapulmonary metastases, such as liver metastasis, bone metastasis, and brain metastasis;
  • Women with pregnancy or lactation.

Who the study is looking for

  • Age \> 18 years old, male and female;
  • According to the Guidelines for the Diagnosis and Treatment of Primary Lung Cancer (2022 edition), the patient was diagnosed with NSCLC by imaging and histopathology;
  • TNM stages were III-IV;
  • Newly diagnosed, first-line treatment failure, refusal or inability to perform conventional treatment (surgery, chemoradiotherapy);
  • ECOG PS ≤2;
  • Expected survival \> 3 months;
  • Sign the informed consent voluntarily, and the compliance is good.

Age in the registry: 18 years to - · Sex: All · Does not accept 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
Gang Wu
Coordinator of this site? Confirm its status
ZhengzhouChinaUnknown status

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