Actively Recruiting
Chemoimmunotherapy Plus Residual Lesion Irradiation for the Treatment of Extensive Stage Small-cell Lung Cancer
Led by Qingdao Central Hospital · Updated on 2024-07-23
70
Participants Needed
3
Research Sites
151 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a phase II trial studies the effect of chemoimmunotherapy sequential residual tumor irradiation in treating patients with extensive stage small cell lung cancer. Even though small cell lung cancer is initially highly responsive to first-line chemotherapy plus PD-L1 inhibitors, treatment resistance inevitably happens. Residual tumor irradiation my prolong drug resistance, and may help prevent the growth and spread of the tumor cells to other parts of the body.
CONDITIONS
Official Title
Chemoimmunotherapy Plus Residual Lesion Irradiation for the Treatment of Extensive Stage Small-cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older
- Eastern Cooperative Oncology Group (ECOG) performance status of 1 or less at treatment start
- Histologically or cytologically confirmed diagnosis of small cell lung cancer (SCLC)
- Extensive stage disease with malignant pleural effusion, contralateral lung pulmonary metastases, or extra-thoracic metastases
- Measurable disease by RECIST 1.1 before starting platinum-based chemotherapy
- Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L
- Platelets ≥ 100 x 10^9/L
- Hemoglobin ≥ 9 g/dL
- Serum creatinine ≤ 1.5 times institutional upper limit of normal (ULN) with creatinine clearance at least 15 ml/min
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 times ULN (≤ 5 times ULN if liver metastases present)
- Total serum bilirubin ≤ 1.5 times ULN (≤ 3 times ULN with normal direct bilirubin in Gilbert's syndrome)
- Ability to understand study and sign informed consent
You will not qualify if you...
- Major surgery within 14 days before starting study drug or incomplete recovery from major surgery side effects (excluding tumor biopsy)
- Positive for immunosuppressive diseases including AIDS or other immune depressing diseases
- Known hypersensitivity to study drug components or analogs
- History or current conditions that could affect study results or participation, including:
- Myocardial infarction or arterial/venous thromboembolic events within 6 months before baseline
- Severe or unstable angina
- New York Heart Association (NYHA) class III or IV disease
- Documented congestive heart failure (NYHA class III or IV) within 6 months prior to baseline
- Poorly controlled arrhythmias
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Qingdao Central Hospital
Qingdao, Shandong, China, 266042
Actively Recruiting
2
Qingdao Central Hospital
Qingdao, Shandong, China, 266042
Actively Recruiting
3
Qingdao Central Hospital
Qingdao, Shandong, China, 266042
Actively Recruiting
Research Team
C
chunling zhang, md
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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