Chemoimmunotherapy Plus Residual Lesion Irradiation for the Treatment of Extensive Stage Small-cell Lung Cancer
Chemoimmunotherapy Plus Ratiotherapy for Extensive Stage Small-cell Lung Cancer
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVE:
I. To evaluate the progression-free survival (PFS) and overall survival of chemoimmunotherapy sequential residual tumor irradiation in patients with extensive stage small cell lung cancer (SCLC).
SECONDARY OBJECTIVES:
II. To assess the overall response rate (ORR) and toxicity in extensive stage SCLC patients treated with chemoimmunotherapy squential residual tumor irradiation
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: chunling zhang, md
- Phone Number: 1718865657
- Email: kevinji78@yahoo.com
Study Locations
-
-
Shandong
-
Qingdao, Shandong, China, 266042
- Recruiting
- Qingdao Central Hospital
-
Contact:
- youxin ji, md
- Phone Number: 86-532-68665078
-
Principal Investigator:
- youxin ji, md
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
>= 18 years of age Have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 1 at the time of study treatment initiation Histologically or cytologically confirmed diagnosis of small cell lung cancer (SCLC) Patient should have extensive stage disease, defined as, malignant pleural effusion, pulmonary metastases in the contralateral lung, and/or the presence of extra-thoracic metastatic disease Must have measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 prior to starting platinum-based systemic 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 x institution upper limit of normal (ULN) and calculated creatinine clearance of at least 15 ml/min.
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 3 x upper limit of normal (ULN) (ALT and AST =< 5 x ULN is acceptable if liver metastases are present) Total serum bilirubin =< 1.5 x ULN. For patients with well documented Gilbert's syndrome, total bilirubin =< 3 x ULN with direct bilirubin within normal range.
Participant must understand the investigational nature of this study and sign an approved written informed consent form prior to receiving any study related procedure.
Exclusion Criteria:
- ad major surgery within 14 days prior to starting study drug or has not recovered from major side effects (tumor biopsy is not considered major surgery) resulting from a prior surgery Positive for immunosuppressive disease, acquired immunodeficiency syndrome (AIDS) or other immune depressing diseases. For human immunodeficiency virus (HIV), HVC and HBC-mandatory testing is required prior to enrollment Patient has known hypersensitivity to the components of the study drugs or any analogs History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate, including, but not limited to: Myocardial infarction or arterial or venous thromboembolic events within 6 months prior to baseline or severe or unstable angina, New York Heart Association (NYHA) class III or IV disease. History of documented congestive heart failure (New York Heart Association functional classification III or IV) within 6 months prior to baseline. Poorly controlled arrhythmias
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Combined chemotherapy and immunotherapy plus residual lesion irradiation
Patients receive carboplatin 5/AUC intravenously (IV) on day 1, adebrelimab 1200mg IV on day 1, and etoposide100mg/m2 IV on days 1-3.
Treatment repeats every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity; redsidual tumor irradiation for 50GY in 25 fraction.
|
lung residual tumor will be given external beam irradiation for 50GY in 25 fractions in total
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
progression-free survival (PFS)
Time Frame: 24 months
|
PFS: time to disease progression or patient death
|
24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Overall survival (OS)
Time Frame: 36 months
|
OS: time to patient death
|
36 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: chunling zhang, md, Qingdao Central Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KY202400902
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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