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

What this Trial Is About

Researchers are evaluating bronchial arterial infusion plus bronchial arterial chemoembolization (BAI-BACE) as a non-first-line treatment for advanced central squamous cell carcinoma of the lung. This study focuses on patients whose cancer has not responded to standard first- or second-line therapies. Lung cancer is a leading cause of cancer death worldwide, and central squamous cell carcinoma represents about a quarter of cases. The trial aims to assess the effectiveness and safety of BAI-BACE, which has been used in some hospitals in China but lacks broad clinical evidence. The treatment involves directly injecting chemotherapy drugs into the tumor through the bronchial artery, achieving high drug concentration quickly to kill tumor cells. Following this, chemoembolization seals off the tumor's blood vessels to restrict its growth. Specifically, paclitaxel is infused slowly over at least 30 minutes, followed by drug-eluting beads loaded with cis-platinum administered until blood flow in the tumor-feeding artery slows or stops. This study is a multicenter, single-arm interventional trial assessing BAI-BACE as a treatment option for advanced cases. Participants will be monitored for progression-free survival over 12 months as the primary outcome, with secondary outcomes including overall survival, tumor response rate, and adverse events over 24 months. Before enrollment, patients will have imaging and blood tests to confirm eligibility. Researchers will assess treatment safety and effectiveness using regular clinical evaluations, imaging, and laboratory tests. The total participation period includes follow-up visits for up to two years to track long-term outcomes and side effects.

BAI-BACE for Advanced Lung Squamous Cell Carcinoma