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Recruiting Phase 2 NCT05443646

Consolidation Serplulimab Following Concurrent Chemoradiotherapy for LS-SCLC Patients

Trial Parameters

Condition Limited Stage Small Cell Lung Cancer
Sponsor Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 55
Sex ALL
Min Age 18 Years
Max Age 75 Years
Start Date 2022-09-23
Completion 2024-06-30
Interventions
HLX10hypofractionated radiotherapyProphylactic Cranial Irradiation (PCI)

Brief Summary

This study is a multi-center, Single-arm Phase II study to evaluate the clinical efficacy and safety of Consolidation HLX10 (Serplulimab) Following Hypofractionated Radiotherapy With Concurrent Chemotherapy for Patients With Limited Stage Small Cell Lung Cancer

Eligibility Criteria

Inclusion Criteria: 1. Age 18-75 years; ECOG score 0-1. 2. Histologically or cytologically confirmed small cell lung cancer. 3. Limited stage, defined as the tumor confined to one side of the thoracic cavity including ipsilateral hilar, bilateral mediastinal, and bilateral supraclavicular lymph nodes, (metastatic lymph nodes are defined as short diameter ≥ 1 cm or increased metabolism on PET-CT considering metastatic lymph nodes); unless cytologically confirmed malignant pleural effusion, the thickness of pleural effusion on chest CT is less than 1 cm; (stage I-IIIB without intrapulmonary metastasis in the 7th edition of AJCC staging in 2009) . 4. No other previous anti-tumor history, at least 3 months of expected survival. 5. No serious medical diseases and dysfunction of major organs, such as blood routine, liver, kidney, heart and lung function. Exclusion Criteria: 1. Histologically or cytologically confirmed mixed SCLC. 2. Subjects suitable for surgery. Subjects who are suitable fo

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