Status:
NOT_YET_RECRUITING
Bronchoscopic Cryoablation Combined With Chemo-Immunotherapy in NSCLC With Central Airway Obstruction
Lead Sponsor:
Hunan Province Tumor Hospital
Conditions:
Non-Small Cell Lung Cancer
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
This study aimed to evaluate the efficacy and safety of bronchoscopic cryoablation combined with sintilimab plus platinum-based chemotherapy as First-line Treatment for locally advanced or metastatic ...
Detailed Description
This is a prospective interventional clinical study to evaluate the efficacy and safety of bronchoscopic cryoablation combined with sintilimab plus platinum-based chemotherapy as First-line Treatment ...
Eligibility Criteria
Inclusion
- Understand the requirements and contents of the clinical trial and provide a signed and dated informed consent form.
- Age≥18 years and≤80 years.
- Histologically or cytologically confirmed and documented locally advanced or metastatic non-small cell lung cancer (NSCLC) without prior systemic therapy and EGFR-sensitive mutations (19del, L858R and T790M).
- Presence of a palliative treatment lesion in the central airway that is amenable to ablation, endoscopically assessed to be≥1/3 obstruction, such as primary or metastatic malignancy to the trachea, main bronchi, intermediate bronchi, or segmental bronchi. corresponding respiratory symptoms or obstructive pneumonia is permission to be included.
- Eastern Cooperative Oncology Group (ECOG) ： 0-2.
- Predicted survival ≥ 12 weeks.
- Adequate bone marrow hematopoiesis and organ function (cardiac function, hepatic, and renal function).
- Presence of measurable lesions according to RECIST 1.1 criteria.
- Subjects with stable brain metastases may be included in the study.
Exclusion
- Histological diagnosis of small cell, large cell lung cancer; mixed tumors will be classified based on the primary cell type; if the primary component is small cell, large cell, or neuroendocrine carcinoma, the subject will not be eligible for enrollment; however, mixed adenocarcinoma-squamous cell carcinoma is acceptable. Subjects with driver gene mutations are generally not eligible for enrollment.
- Malignant central airway obstruction with acute dyspnea or severe life-threatening symptoms of malignant airway stenosis, or assessed by the investigator to be unable to tolerate subsequent treatment; extrinsic airway compression; large pleural effusion, severe coughing, massive hemoptysis, dyspnea, or inability to cooperate; severely impaired lung function with a maximal voluntary ventilation (MVV) \< 39% or inability to ambulate.
- Prior systemic therapy for locally or metastatic disease.
- Uncorrectable coagulation disorders, severe bleeding tendencies, platelet count \< 50 \*10\^9/L, or severe coagulation dysfunction.
- Presence of symptomatic brain metastases.
- Known severe hypersensitivity to anti-PD-1 monoclonal antibodies or similar drugs (allergic reactions with CTCAE≥ grade 3 toxicity).
- Subjects with persistent or active infection, including but not limited to hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV).
- Any concurrent malignancy other than basal cell carcinoma or cervical carcinoma in situ. (Patients with a history of malignant tumors but with no evidence of disease for≥ 3 years may be included ).
- Women who are breastfeeding or pregnant.
- Other conditions assessed by the investigator to be unsuitable for participation in the study.
Key Trial Info
Start Date :
September 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2029
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT06604351
Start Date
September 15 2024
End Date
May 31 2029
Last Update
September 19 2024
Active Locations (1)
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1
Hunan Cancer hospital
Changsha, Hunan, China