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A Single-Arm Trial of Hematopoietic Stem Cell Transplantation-Supported Dose-Dense Chemotherapy with Adebrelimab As First-Line Treatment for Extensive-Stage Small-Cell Lung Cancer
The goal of this clinical trial is to learn if hematopoietic stem cell transplantation-supported dose-dense chemotherepy with adebrelimb works to treat extensive-stage small-cell lung cancer in adults. It will also assess the safety of this treatment approach. The main questions it aims to answer are: Does hematopoietic stem cell transplantation-supported dose-dense chemotherepy with adebrelimb improve the median progression free survival and 12-months overall survival rates? What medical problems do participants experience whild undergoing this treatment? Participants will: Complete two 21-days cycles of standard-dose etoposide and carboplatin, followed by G-CSF for stem cell mobilization. Receive dose-dense chemotherapy followed by autologous stem cell reinfusion for two 21-day cycles. If eligible, participants will receive etoposide and carboplatin plus adebrelimab for four cycles. Finally, participants may enter a maintenance phase with adebrelimab. Throughout the trial, participants will: Visit the clinic every 21 days for check-ups and tests. Imaging examination every 6 weeks. Followed up by telephone every 2 months
Details
| Lead sponsor | Zhou Chengzhi |
|---|---|
| Phase | Phase 1/Phase 2 |
| Status | NOT_YET_RECRUITING |
| Enrolment | 10 |
| Start date | 2024-12 |
| Completion | 2026-12 |
Conditions
- Extensive Stage Small Cell Lung Cancer
Interventions
- auto-HSCT-Supported Dose-Dense Chemotherapy With Adebrelimab
Primary outcomes
- Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v5.0 — Time Frame: Followed up every 21 days.
Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v5.0, detailed descriptions of the events, the onset timing, severity grade, therapeutic interventions undertaken, and the potential correlation with the investigational medication.