Actively Recruiting

Phase 2
Age: 18Years - 80Years
All Genders
NCT05892237

CIETAI and Sequential Radiotherapy in Squamous Lung Cancer

Led by Dong Wang · Updated on 2023-08-23

50

Participants Needed

1

Research Sites

152 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

CIETAI and Sequential Radiotherapy in Squamous Lung Cancer

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients volunteered to participate in the study and signed the informed consent.
  • Age 18-80, both male and female.
  • Histologically or cytologically confirmed squamous lung cancer staging T3-4, Nany, and M0 (AJCC 2017 Edition 8 TNM Staging System).
  • Central-type lung cancer classified by chest imaging or bronchoscopy.
  • At least one measurable lesion according to RECIST 1.1.
  • ECOG Performance Status 0-1.
  • Expected survival of at least 6 months.
  • Patients who never received systemic therapy before or relapsed more than 6 months after adjuvant chemotherapy.
  • Main organ functions within specified limits for blood counts, liver and kidney function, and heart function within 7 days before treatment.
  • Tissue samples provided for biomarker analysis or archival tissue available; blood samples for MRD analysis (non-mandatory).
Not Eligible

You will not qualify if you...

  • Severe allergic reactions to humanized antibodies or fusion proteins.
  • Severe allergic reactions to components of contrast agents or embolism agents.
  • Metastasis to bone, brain, liver, pleural cavity, or other distant organs.
  • Diagnosed immunodeficiency or systemic immunosuppressive therapy within 14 days before study (except low-dose glucocorticoids).
  • Active or suspected autoimmune diseases, except certain controlled skin disorders.
  • Serious heart diseases including congestive heart failure, high-risk arrhythmia, unstable angina, myocardial infarction, or severe valvular disease.
  • Prior systemic antineoplastic therapy or radiotherapy within specified recent periods.
  • Positive hepatitis B or C infection indicating acute or chronic infection.
  • Active pulmonary tuberculosis infection currently or within the past year unless properly treated.
  • Brain metastases with symptoms or symptoms controlled for less than 2 months.

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Daping Hospital, Third Military Medical University

Chongqing, Chongqing Municipality, China, 400042

Actively Recruiting

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Research Team

D

Dong Wang, ph.D

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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