NCT05892237

CIETAI and Sequential Radiotherapy in Squamous Lung Cancer

Recruiting now Phase 2 Last updated 23 August 2023

What this trial tests

Phase 2 trial testing bronchial artery interventional therapy in Carcinoma, Non-Small-Cell Lung in 50 participants. Currently enrolling.

Timeline

1 July 2023

Primary endpoint
1 February 2025

1 June 2026

Quick facts

Lead sponsor	Dong Wang
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	50
Start date	1 July 2023
Primary completion	1 February 2025
Estimated completion	1 June 2026
Sites	1 location across China

Drugs / interventions tested

• bronchial artery interventional therapy
• Chemotherapy drug — full drug profile →
• IMRT
• Immunotherapy — full drug profile →

Conditions studied

• Carcinoma, Non-Small-Cell Lung — all drugs for Carcinoma, Non-Small-Cell Lung →

Sponsor

Dong Wang — full company profile →

Who can join

Adults 18 to 80, any sex, with Carcinoma, Non-Small-Cell Lung. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.