Extensive Stage Small Cell Lung Cancer
Conditions
Brief summary
The purpose of this study is to assess efficacy and safety of patients who receive Adebrelimab combined with chemotherapy±chest radiotherapy as first-line treatment of extensive stage small cell lung cancer in the real world.
Interventions
DRUGAdebrelimab + chemotherapy
Adebrelimab: 1200mg, d1, iv (30-60min), Q3W ,up to progressive disease or toxicity intolerable Chemotherapy: etoposide 100mg/m2，d1-3，iv；carboplatin AUC=5-6，d1，iv；or cisplatin 75mg/m2，d1，iv，Q3W，4 cycles；
RADIATION±chest radiotherapy
Chest radiotherapy: 3Gy/15f-18f or 2Gy/20f-25f
Sponsors
Hebei Medical University Fourth Hospital
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
1. Age:≥18 years old; 2. Patients with extensive stage small cell lung cancer confirmed by histopathology; 3. Normal function of major organs; 4. Participants were willing to join in this study, and written informed consent, good adherence, cooperate with the follow-up.
Exclusion criteria
1. Patients with drug allergy sufferers; 2. Serious and uncontrolled organic lesions or infections, such as decompensated heart, lung, kidney failure, etc; 3. History of psychiatric drugs abuse and can't quit or patients with mental disorders; 4. The researchers think inappropriate.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression free survival (PFS) | evaluated in 24 months since the treatment began | Baseline to measured date of progression or death from any cause |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate (ORR) | tumor assessment every 6 weeks since the treatment began，up to 24 months | Baseline to measured stable disease |
| Disease control rate (DCR) | tumor assessment every 6 weeks since the treatment began，up to 24 months | Baseline to measured progressive disease |
| Duration of Overall Response（DoR） | tumor assessment every 6 weeks since the treatment began，up to 24 months | The duration of overall response is measured from the time that measurement criteria are met for complete response or partial response until the first date that recurrent or progressive disease is objectively documented |
| Overall survival (OS) | the first day of treatment to death or last survival confirm date,up to 24 months | Baseline to measured date of death from any cause |
| Adverse events | up to 24 months | Toxicity according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03. The number of Participants with adverse events will be recorded at each treatment visit |
Countries
China
Outcome results
None listed