CIETAI and Sequential Radiotherapy in Squamous Lung Cancer - Trial NCT05892237

Timeline & Enrollment

Primary Outcome

Objective Response Rate 2 (ORR2)

Summary

Central-type lung cancer refers to lung malignancies originating from the segmental bronchi
 and above. The most common tissue type is squamous cell carcinoma. Patients often present
 with cough, hemoptysis, hoarseness and also some critical conditions including superior vena
 caval obstruction syndrome. Therefore, effective treatment should be implemented as early as
 possible to rapidly reduce tumor burden and control the progression of the disease. Most of
 the central-type NSCLC are classified into T3-4, N1-2 stage and are non-resectable. The
 PACIFIC study changed the standard treatment model for inoperable locally advanced lung
 cancer with synchronous chemoradiotherapy and sequential PD-L1 immunotherapy. In clinical
 practice, Chinese patients often failed to finish concurrent chemoradiotherapy for high
 toxicity. In addition, combination with PD-1/PD-L1 inhibitors increased the risk of immune
 related pneumonia.
 
 Bronchial artery infusion (BAI), that directly infused drugs (chemo and PD-1 inhibitor)
 through tumor-nourishing arteries, has potential advantages in the treatment of central-type
 lung cancer. The drug concentration in tumor region increased to potentiate the antitumoral
 effect and also reduced the systemic adverse reactions.
 
 In this study, bronchial artery interventional therapy is conducted with precedence. The
 protocol for bronchial artery intervention includes infusion of chemo and PD-1 inhibitor
 followed by bronchial artery embolism (Chemo-Immulo-embolization via Tumor arterial, CIETAI).
 Followed CIETAI, two cycles of chemo/PD-1 therapy are planned to carried out before
 radiotherapy. After radiotherapy, maintenance PD-1 inhibitor are initiated for 1 year or
 until progression.

ICD-10 Classifications