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

Recruiting

• Conditions: Extensive Stage Small Cell Lung Cancer
• Interventions: Drug: Adebrelimab + chemotherapy; Radiation: ±chest radiotherapy

• Registration Number: NCT06323265
• Lead Sponsor: Hebei Medical University Fourth Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-03
• Study First Submitted: 2024-03-14
• Study First Submitted QC: 2024-03-14
• Study First Posted: 2024-03-21
• Study Start: 2024-03-26
• Last Update Submitted: 2024-03-26
• Last Update Posted: 2024-03-27
• Primary Completion: 2025-04-01
• Study Completion: 2026-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Experimental	±chest radiotherapy	-
Experimental	Adebrelimab + chemotherapy	-

Primary Outcome Measures

Name	Time	Method
Progression free survival (PFS)	evaluated in 24 months since the treatment began	Baseline to measured date of progression or death from any cause

Secondary Outcome Measures

Name	Time	Method
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
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
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

Trial Locations

Locations (1)

Jun Wang; 🇨🇳 Shijiazhuang, Hebei, China