RecruitingNot ApplicableNCT06377735

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

Sponsor

Sun Yat-sen University

Enrollment

85 participants

Start Date

May 1, 2024

Study Type

INTERVENTIONAL

Conditions

Squamous Cell Carcinoma

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria11

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.

Exclusion Criteria9

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

Interventions

PROCEDUREBAI-BACE

Bronchial arterial infusion, bronchial arterial chemoembolization (BACE-BAI) procedure was performed as follows: Bronchial arteriography was performed to find tumor-feeding artery. After the catheter had been inserted into the tumor-feeding artery, paclitaxel (300 mg) was infused slowly at least 30 min. BAI (bronchial arterial infusion) chemotherapy was followed by BACE (Drug-eluting beads bronchial arterial chemoembolization); the CalliSpheres loaded with cis-platinum (30 mg) were infused into the tumor-feeding arteries until stasis or near-stasis of blood flow in the vessel was observed.