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This retrospective real-world study aims to evaluate the efficacy and safety of anlotinib hydrochloride combined with immunotherapy as maintenance therapy following standard chemoimmunotherapy in extensive-stage small cell lung cancer (ES-SCLC).The study population consists of treatment-naïve ES-SCLC patients who did not progress after induction chemoimmunotherapy and subsequently received maintenance therapy with anlotinib plus immunotherapy. The primary objectives are progression-free survival (PFS),overall survival (OS)
, and safety.
This multicenter study seeks to retrospectively analyze medical records (January 2022-December 2024) of extensive-stage small cell lung cancer (ES-SCLC) patients treated with anlotinib hydrochloride (12/10/8 mg doses) alongside immune maintenance therapy after first-line chemoimmunotherapy in real-world clinical settings. Key data points will encompass demographics, baseline disease characteristics, treatment regimens, efficacy outcomes (e.g., objective response rate, progression-free survival), and adverse event profiles. Eligible patients must have received anlotinib for ≥6 weeks and possess evaluable radiographic assessments. The primary objectives are to assess the clinical effectiveness and safety of this combination strategy in ES-SCLC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group | patients treated with anlotinib Hydrochloride combined with immunotherapy maintenance therapy following standard chemoimmunotherapy. |
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| Measure | Description | Time Frame |
|---|---|---|
| PFS2 | Progression-free survival from the initiation of anlotinib combined with immunotherapy maintenance treatment. | up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| PFS | Progress free survival | up to 12 months |
| 6-month PFS rate | Progress free survival rate at 6 months after diagnosis. | up to 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with treatment-naïve extensive-stage small cell lung cancer (ES-SCLC) who achieved non-progression after chemoimmunotherapy induction and received anlotinib plus immunotherapy maintenance therapy
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| 12-month PFS rate | Progress free survival rate at 12 months after diagnosis. | up to 12 months |
| OS | Overall Survival | From diagnosis until death (up to 24 months) |
| 6-month OS rate | Overall survival rate at 6 months after diagnosis. | up to 12 months |
| 12-month OS rate | Overall survival rate at 12 months after diagnosis. | up to 24 months |
| Incidence of Treatment-Emergent Adverse Events | Record Adverse Events (AEs) according to CTCAE (V5.0). Record and analyze the number of abnormal data. | up to 24 months |