Adebrelimab + Apatinib in SCLC Maintenance Therapy

Sponsor
Tang-Du Hospital
Study ID
NCT06475209
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Adebrelimab combined with Apatinib — DRUG
    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.

Study Details

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.

Key Dates

Start date
Jun 20, 2024
Status verified
Jun 2024
Primary completion
Dec 20, 2025
Completion
Dec 20, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Adebrelimab combined with Apatinib
    Evaluation of the Efficacy and Safety of Adebrelimab in Combination with Apatinib in Maintenance Therapy for Extensive-Stage Small Cell Lung Cancer Each treatment cycle spans 3 weeks. Sequential medication administration begins on the first day of each cycle: Adebrelimab 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.

Primary Outcome Measure

Progression-free survival [ Time Frame: Progression-free survival (PFS) analysis based on investigator assessment per RECIST 1.1, and will be assessed up to 2 years ]

Central Contacts

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