A Study of Adebrelimab Combined With Apatinib Mesylate and Chemotherapy for Neoadjuvant Therapy and Biomarker Analysis in Limited-stage Small Cell Lung Cancer
NCT06483282 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 38
Last updated 2025-04-15
Summary
This is a single-arm, prospective, exploratory phase II clinical study. The study enrolled newly diagnosed stage T1-3N0-1M0 resectable limited-stage small cell lung cancer. Adebrelimab combined with chemotherapy for 4 cycles and apatinib mesylate for 3 cycles. Surgery was performed within 4-8 weeks after the above treatment (the operation was performed 4 weeks after apatinib was discontinued). According to the results of MDT discussion, adebrelimab combined with apatinib mesylate combined with or without radiotherapy was started 4 weeks after surgery. Preoperative prophylactic radiotherapy (PCI) is recommended for patients with preoperative stage N1. Patients with postoperative stage N1 received postoperative thoracic radiotherapy.
Conditions
- Small Cell Lung Cancer Limited Stage
Interventions
- DRUG
-
Adebrelimab
This product is administered by intravenously guttae. The recommended dose of subcutaneous injection is 20mg/kg, administered every 3 Weeks (Q3W).
- DRUG
-
Apatinib Mesylate
This product is an orally administered targeted therapy drug, with a recommended dosage of one tablet per day.
- DRUG
-
Etoposide
This product is administered by intravenously guttae. The recommended dose of subcutaneous injection is 100mg/m2, administered every 3 Weeks (Q3W).
- DRUG
-
This product is administered by intravenously guttae. AUC=5, administered every 3 Weeks (Q3W).
Sponsors & Collaborators
-
Jin Ying
lead OTHER
Principal Investigators
-
Da Chen, MD&PhD · Medical Ethics Committee Of Zhejiang Cancer Hospital
-
Zhengfu He, MD&PhD · Sir Run Run Shaw Hospital
-
Zhengliang Tu, MD&PhD · Zhejiang University
-
Junqiang Fan, MD&PhD · Second Affiliated Hospital, School of Medicine, Zhejiang University
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-06-21
- Primary Completion
- 2026-06-01
- Completion
- 2026-12-31
Countries
- China
Study Locations
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