TRT for ES-SCLC After First Line Treatment With Immune Checkpoint Inhibitors

Study Overview
=================
Brief Summary
-----------------
To Evaluate the Safety and Efficacy of Thoracic Radiotherapy for?ES-SCLC After First Line Treatment with Immune Checkpoint Inhibitors.

Official Title
-----------------
An Open-label, Phase II Single Arm Trial of Thoracic Radiotherapy for?ES-SCLC After First Line Treatment With Immune Checkpoint Inhibitors

Conditions
-----------------
SCLC,Extensive Stage

Intervention / Treatment
-----------------
* Radiation: Thoracic radiotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age at least 18 years. ECOG PS 0-1. Histological or cytological syndrome of small cell lung cancer, imaging evaluation staging is extensive Life expectancy >= 3 months. Patients are non-progressed after 4 dosed of immunotherapy plus platinum based chemotherapy, with residual thoracic lesions Palliative radiotherapy were allowed except for TRT, the interval > 4 weeks Adequate organ function prior to enrollment: Adequate bone marrow function: white blood cell (WBC) count ≥ 3.0 * 10 ^ 9/L or neutrophil count ≥ 1.5 * 10 ^ 9/L, platelet count ≥ 100 * 10 ^ 9/L and hemoglobin ≥90g/L,; Adequate hepatic function: total bilirubin, urea nitrogen and serum creatinine≤ 1.5 x upper limit of normal (ULN). Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤2.0 ULN; Sufficient heart and lung function, EF>55%FEV1>50% Ability to understand and willingness to provide the informed consent. Women of childbearing age and men must agree to use effective contraception during the trial. Exclusion Criteria: History of another malignancy or concurrent malignancy; Mixed small cell with non-small cell lung cancer histology; History of thoracic radiotherapy; Malignant pleural or ascites; Patients with leptomeningeal metastasis or uncontrolled brain; Severe autoimmune disease: inflammatory bowel disease (including Crohn's disease and ulcerative colitis), rheumatoid arthritis, scleroderma, systemic lupus erythematosus, Wegener's granulomatosis and related vasculitides. Symptomatic interstitial lung disease or clinically active infectious/non-infectious pneumonitis. Active infection, congestive heart failure, or any evidence of myocardial infarction, unstable angina pectoris or cardiac arrhythmia within 6 months prior to enrollment. The patient is pregnant (confirmed by serum b-HCG if applicable) or is breastfeeding. Mental disorders, drug abuse, and social condition that may negatively impact compliance in the investigator's opinion.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TRT<br>Patients with es-SCLC after first line treatment with immune checkpoint inhibitors will be treated with thoracic radiotherapy. | Radiation: Thoracic radiotherapy<br>* Thoracic radiotherapy for ES-SCLC after first line immunecheckpoint inhibitors<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local recurrence free survival | From the date of enrollment to the date of local recurrence | 2 years | 
| Adverse events | Treatment-related adverse events according to CTCAE 5.0. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progress free survival | From the date of enrollment to the date of disease progression | 2 years | 
| Overall survival | from the date of enrollment until death by any cause or last follow-up | 2 years |