A Real-world Study of Adebrelimab Combined With Chemotherapy±Chest Radiotherapy in Patients With Extensive Stage Small Cell Lung Cancer

Hebei Medical University Fourth Hospital50 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Extensive Stage Small Cell Lung Cancer

Interventions

Adebrelimab + chemotherapyDRUG

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；

±chest radiotherapyRADIATION

Chest radiotherapy: 3Gy/15f-18f or 2Gy/20f-25f

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Jun Wang

Shijiazhuang, Hebei, China

RECRUITING

Outcomes

Primary Outcomes

Progression free survival (PFS)

Baseline to measured date of progression or death from any cause

Time frame: evaluated in 24 months since the treatment began

Secondary Outcomes

Objective response rate (ORR)

Baseline to measured stable disease

Time frame: tumor assessment every 6 weeks since the treatment began，up to 24 months

Disease control rate (DCR)

Baseline to measured progressive disease

Time frame: tumor assessment every 6 weeks since the treatment began，up to 24 months

Duration of Overall Response（DoR）

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

Time frame: tumor assessment every 6 weeks since the treatment began，up to 24 months

Overall survival (OS)

Baseline to measured date of death from any cause

Time frame: the first day of treatment to death or last survival confirm date,up to 24 months

Adverse events

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

Time frame: up to 24 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.