Clinical trial NCT05544149: TRT 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: SCLC,Extensive Stage
Lead sponsor: Zhejiang Cancer Hospital
Sponsor class: OTHER
First posted: 2022-09-16
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Local recurrence free survival
timeFrame: 2 years
measure: Adverse events
timeFrame: 2 years
Secondary outcomes:
measure: Progress free survival
timeFrame: 2 years
measure: Overall survival
timeFrame: 2 years
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
affiliation: Department of Thoracic Radiotherapy, Zhejiang Cancer Hospital
name: Xiaojing Lai
role: PRINCIPAL_INVESTIGATOR
References: