TRT for ES-SCLC After First Line Treatment With Immune Checkpoint Inhibitors
Phase 2
Recruiting
- Conditions
- SCLC,Extensive Stage
- Interventions
- Radiation: Thoracic radiotherapy
- Registration Number
- NCT05544149
- Lead Sponsor
- Zhejiang Cancer Hospital
- Brief Summary
To Evaluate the Safety and Efficacy of Thoracic Radiotherapy for?ES-SCLC After First Line Treatment with Immune Checkpoint Inhibitors.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 42
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description TRT Thoracic radiotherapy Patients with es-SCLC after first line treatment with immune checkpoint inhibitors will be treated with thoracic radiotherapy.
- Primary Outcome Measures
Name Time Method Adverse events 2 years Treatment-related adverse events according to CTCAE 5.0.
Local recurrence free survival 2 years From the date of enrollment to the date of local recurrence
- Secondary Outcome Measures
Name Time Method Overall survival 2 years from the date of enrollment until death by any cause or last follow-up
Progress free survival 2 years From the date of enrollment to the date of disease progression
Trial Locations
- Locations (1)
Zhejiang Cancer Hospital
🇨🇳Hangzhou, Zhejiang, China