The Efficacy and Safety of Serplulimab in the Treatment of Limited-Stage Small Cell Lung Cancer
Conditions
Interventions
Serplulimab combined with radiotherapy (or surgery) group:None
Standard Radiotherapy and Chemotherapy Group:None
Sponsors
The Second Affiliated Hospital of Army Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients diagnosed with limited-stage small cell lung cancer (LS-SCLC) according to the Chinese Medical Association's Clinical Guidelines for Lung Cancer Diagnosis and Treatment (2023 edition) and the World Health Organization's Tumor Classification (2021, 5th edition). 2. Patients who received serplulimab in combination with chemotherapy ± radiotherapy or ± surgery, or standard chemotherapy +/- radiotherapy, and had not previously received any other systemic treatment for the tumor. 3. Patients aged >=18 years, regardless of gender. 4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1. 5. According to the Response Evaluation Criteria in Solid Tumors (RECIST 1.1), patients had at least one unidimensionally measurable lesion with a longest diameter >=10 mm, as measured by spiral CT.
Exclusion criteria
Exclusion criteria: 1. Patients with other malignancies within 3 years or currently suffering from other malignancies. The following two situations are eligible for enrollment: Other malignancies treated with single surgery and achieved continuous 5-year disease-free survival (DFS); Cured cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor invades the basement membrane)]. 2. Patients with missing or unclear case information. 3. Patients with lymph node metastasis classified as N3. 4. Patients who have already been enrolled in other clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease-Free Survival;Overall Survival;Objective Response Rate;Duration of Response;Disease Control Rate;Adverse Events; | — |
Countries
China
Contacts
Public ContactXu Zhi
The Second Affiliated Hospital of Army Medical University
Outcome results
None listed