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RECRUITING
NCT06475209
PHASE2

Adebrelimab + Apatinib in SCLC Maintenance Therapy

Sponsor: Tang-Du Hospital

View on ClinicalTrials.gov

Summary

This prospective clinical study aims to evaluate and observe the efficacy and safety of Atezolizumab combined with Apatinib in maintenance therapy for extensive-stage small cell lung cancer using a single-arm trial design. The study is planned to be conducted in Shaanxi Province, China, with an initial target enrollment of 60 patients. The study commenced in February 2024, and recruitment is expected to conclude around December 2025, with the trial anticipated to end by December 2026. Assuming no occurrences such as withdrawal of informed consent by subjects, intolerable adverse drug reactions, or investigator-assessed unsuitability for further participation, each participant's estimated duration of study treatment will continue until radiographically confirmed tumor progression.

Official title: Observational Study on the Efficacy and Safety of Adebrelimab Combined With Apatinib in Maintenance Therapy for Extensive-Stage Small Cell Lung Cancer

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2024-06-20

Completion Date

2026-12-20

Last Updated

2024-06-26

Healthy Volunteers

No

Conditions

Interventions

DRUG

Adebrelimab combined with Apatinib

Each treatment cycle spans 3 weeks. Sequential medication administration begins on the first day of each cycle: Atezolizumab is administered at a dosage of 1200mg on day 1, every 3 weeks, while Apatinib is given orally at a dosage of 250mg daily from day 1 to day 14, every 3 weeks, with a one-week hiatus following two weeks of continuous intake. Administration timing allows for a window of ±5 days. Subjects are required to undergo comprehensive assessments, including vital signs monitoring, anthropometric measurements, physical examinations, laboratory analyses, and performance status evaluations, to assess treatment tolerability for continuation.

Locations (1)

Tangdu Hospital Affiliated to the Fourth Military Medical University

Xi'an, Shannxi, China