RecruitingPhase 2NCT05892237

CIETAI and Sequential Radiotherapy in Squamous Lung Cancer

Bronchial Artery Interventional Therapy and Sequential Radiotherapy in the Treatment of Non-resectable, Non-metastatic Central-type Squamous Lung Cancer


Sponsor

Dong Wang

Enrollment

50 participants

Start Date

Jul 1, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combined approach of immunotherapy, chemotherapy, and sequential radiation therapy for people with locally advanced squamous cell lung cancer that has not spread to other organs. **You may be eligible if...** - You are between 18 and 80 years old - You have squamous cell lung cancer confirmed by biopsy, staged T3–4 (locally advanced) without distant spread (M0) - You signed informed consent voluntarily **You may NOT be eligible if...** - Your cancer has spread to distant organs (M1) - You are outside the 18–80 age range - You have conditions making immunotherapy or chemotherapy unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREbronchial artery interventional therapy

After successful anesthesia, right femoral artery puncture was performed by Seldinger method. 5F-Yashrio catheter is chosen to locate the bronchial artery of the diseased side at the level of the thoracic aortotracheal bifurcation. Angiography was performed (Osu 300mg/ml, 3ml/s, total 8ml, 200Psi) to visualize tumor blood supply artery before infusion of chemo+PD-1 inhibitor and embolism.

DRUGChemotherapy drug

Nano-paclitaxel 260 mg/m2, d1, ivgtt, q3w+Cisplatin 75mg/m2, d1, ivgtt,q3w.

RADIATIONIMRT

60Gy/2Gy/30f

DRUGImmunotherapy

PD-1 inhibitor (Tirelizumab) 200mg, d1, ivgtt, 30-60min, q3w.


Locations(1)

Daping Hospital, Third Military Medical University

Chongqing, Chongqing Municipality, China

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NCT05892237


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