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This prospective clinical study aims to evaluate and observe the efficacy and safety of adebrelimab combined with etoposide capsules in maintenance therapy for extensive-stage small cell lung cancer using a single-arm trial design.
The study is planned to be conducted in Shaanxi Province, China, with an initial target enrollment of 32 patients. The study commenced in August 2025, and recruitment is expected to conclude around December 2026, with the trial anticipated to end by December 2027. Assuming no occurrences such as withdrawal of informed consent by subjects, intolerable adverse drug reactions, or investigator-assessed unsuitability for further participation, each participant's estimated duration of study treatment will continue until radiographically confirmed tumor progression.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adebrelimab combined with Etoposide Capsules | Drug | Each treatment cycle spans 3 weeks. Sequential medication administration begins on the first day of each cycle: Adebrelimab is administered at a dosage of 1200mg on day 1, every 3 weeks, while Etoposide Capsules is given orally at a dosage of 50mg or 25mg daily, day 1 to 14 of a 21-day cycle. Administration timing allows for a window of ±5 days. Subjects are required to undergo comprehensive assessments, including vital signs monitoring, anthropometric measurements, physical examinations, laboratory analyses, and performance status evaluations, to assess treatment tolerability for continuation. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | Progression free survival (PFS) refers to the time from recording the first chemotherapy treatment to the date of disease progression, as assessed by researchers. | Progression-free survival (PFS) analysis based on investigator assessment per RECIST 1.1, and will be assessed up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Overall survival (OS) refers to the time that researchers evaluate from recording the first chemotherapy to death (of any cause). | The maximum time from receiving treatment to dying for any reason is 4 years. |
| Objective response rate |
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Inclusion Criteria:
(1)Bone marrow function: Absolute neutrophil count (ANC) ≥ 1.5×10^9/L (grade 1 according to CTCAE 5.0); platelets ≥ 100×10^9/L; hemoglobin > 80g/L.
(2)Renal function: Creatinine ≤ 1.5 times the upper limit of normal (ULN), grade 1 according to CTCAE. Note: If creatinine is greater than 1.5 times the ULN, creatinine clearance must be > 50ml/min.
(3)Liver function: Bilirubin ≤ 1.5 times ULN (grade 1 according to CTCAE), patients with Gilbert's syndrome bilirubin ≤ 3.0 times ULN; AST and ALT ≤ 3.0×ULN.
(4)Coagulation indicators: International normalized ratio (INR) ≤ 1.55 (if the patient is receiving a stable dose of therapeutic warfarin or low molecular weight heparin, INR is usually between 2 and 3), PTT < 1.2 times ULN.
10.Women of childbearing potential must agree to use contraception during the study and for 6 months after the end of the study (such as an intrauterine device, contraceptive pills, or condoms); serum or urine pregnancy test must be negative within 1 week before enrollment, and must be non-lactating patients; men must agree to use contraception during the study and for 6 months after the end of the study.
Exclusion Criteria:
(1)Untreated or symptomatic brain metastases or spinal cord compression; (2)Concurrent active malignancy requiring treatment; (3)Active autoimmune disease or immunodeficiency, or a history of such conditions, including but not limited to autoimmune hepatitis, interstitial lung disease, uveitis, rheumatoid arthritis, inflammatory bowel disease, hypophysitis, vasculitis, or nephritis.Exceptions include: patients with stable disease not requiring systemic immunosuppressive therapy, such as type I diabetes mellitus, hypothyroidism controlled with hormone replacement therapy, or skin disorders not requiring systemic treatment (e.g., vitiligo, psoriasis, or alopecia), or those with no external triggering factors and a low risk of recurrence; (4)History of psychiatric or substance abuse disorders that would interfere with study compliance; 8.Presence of any severe and/or uncontrolled comorbid conditions, including but not limited to:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lei Pan, Dr | Contact | 13991161903 | panlei@fmmu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tangdu Hospital Affiliated to the Fourth Military Medical University | Recruiting | Xi'an | Shannxi | 710000 | China |
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| ID | Term |
|---|---|
| D005047 | Etoposide |
| ID | Term |
|---|---|
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
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Per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) using Investigator assessments, is defined as the number (%) of patients with response of Complete Response or Partial Response, will be assessed up to 1 years. |
| Data obtained up until progression, or the last evaluable assessment in the absence of progression, will be assessed up to 1 years. |
| Duration of Response | Duration of Response(DoR)refers to the time from the first assessment as CR or PR to the first assessment as PD or (due to any reason) death. | Duration of Response(DoR)analysis based on investigator assessment per RECIST 1.1, and will be assessed up to 1 years. |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |