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Auto-HSCT-Supported Dose-Dense Chemotherapy with Adebrelimab As First-Line Treatment for ES-SCLC

NCT06597513 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2024-10-15

No results posted yet for this study

Summary

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

Conditions

Interventions

DRUG

auto-HSCT-Supported Dose-Dense Chemotherapy With Adebrelimab

Induction: Two 21-day cycles of standard-dose etoposide 80-100 mg/m² on days 1-3 and carboplatin AUC 5-6 on day 1. Those without disease progression will advance to consolidation treatment. Consolidation: Stem cell mobilization with G-CSF will be start when white blood cell count is at its nadir post-chemotherapy. After recovery, peripheral blood stem cells will be collected via apheresis, evaluated, and cryopreserved if adequate. Dose-dense etoposide 160-200 mg/m² on days 1-3 and carboplatin AUC 10-12 on day 1 for two 21-day cycles. Within 48-72 hours after the first cycle, autologous peripheral blood stem cells will be reinfused with G-CSF. Further consolidation will depend on hematopoietic recovery with standard-dose EC plus adebrelimab 1200 mg on day 1 for four 21-day cycles. Maintenance: Adebrelimab 1200 mg every 21 days will be given until disease progression, intolerable toxicity, death, patient withdrawal, or investigator decision.

Sponsors & Collaborators

  • Zhou Chengzhi

    lead OTHER

Principal Investigators

  • Chengzhi Zhou, MD · The First Affiliated Hospital of Guang Zhou Medical University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-31
Primary Completion
2025-12-31
Completion
2026-12-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06597513 on ClinicalTrials.gov