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This study plans to enroll limited-stage small cell lung cancer (LS-SCLC) patients who have achieved disease control after concurrent chemoradiotherapy (cCRT). Tissue samples collected at initial diagnosis and serial peripheral blood samples obtained at multiple post-cCRT timepoints will be analyzed using targeted next-generation sequencing to investigate the correlation between molecular residual disease (MRD) status and tumor recurrence/metastasis. For patients with MRD-positive results, a therapeutic strategy combining immunotherapy with anti-angiogenic agents will be implemented with the aim of improving clinical outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MRD-positive group | Experimental | The specific dosing regimen is as follows: Adebrelimab: Intravenous infusion, 1200 mg, administered on Day 1 of each cycle, once every 3 weeks. Apatinib: Oral administration, 250 mg, once daily. Patients with limited-stage small cell lung cancer who have completed all radical chemoradiotherapy (prophylactic cranial irradiation is permitted) and test positive for MRD upon enrollment, without prior use of immune checkpoint inhibitors, will receive adebrelimab combined with apatinib according to the above dosing regimen. Treatment with adebrelimab and apatinib will continue, along with ongoing ctDNA monitoring. The above treatment regimen will be maintained until disease progression, intolerable toxicity, completion of two years of treatment, subject-initiated withdrawal, or investigator-determined discontinuation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adebrelimab Injection | Drug | Patients with MRD Positive will receive adebrelimab (1200 mg, D1, Q3W) , followed by ctDNA monitoring every 2 months (Year 1) and every 3 months (Year 2).The above treatment regimen will be maintained until disease progression, intolerable toxicity, completion of two years of treatment, subject-initiated withdrawal, or investigator-determined discontinuation. |
| Measure | Description | Time Frame |
|---|---|---|
| Negative conversion rate of MRD | Patients with limited-stage small cell lung cancer (LS-SCLC) receive concurrent chemoradiotherapy in accordance with standard diagnostic and treatment guidelines. Patients who are MRD-positive after completion of concurrent chemoradiotherapy and have not previously been treated with immune checkpoint inhibitors are screened and enrolled to receive the investigational treatment regimen. We then calculate the proportion of patients whose MRD status converts from positive to negative following treatment. | MRD is assessed at 60-day intervals during the first year and 90-day intervals during the second year, until disease progression, study discontinuation for any reason, or completion of 2 years of follow-up, whichever occurs first. |
| Measure | Description | Time Frame |
|---|---|---|
| PFS | Progression-Free Survival (PFS) is defined as the time interval from randomization (or treatment initiation in single-arm studies) to the first occurrence of either: Radiographically or pathologically confirmed disease progression(RECIST1.1), or Death from any cause; whichever is observed first. | Imaging assessments are performed every 3 months. After each assessment, treatment response is evaluated by senior experts according to the Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1. The maximum follow-up duration is 2 years. |
| Measure | Description | Time Frame |
|---|---|---|
| Dynamic Changes in Absolute Counts and Activation Status of Peripheral Blood Lymphocyte Subsets | Patients with limited-stage small cell lung cancer (LS-SCLC) receive concurrent chemoradiotherapy in accordance with standard diagnostic and treatment guidelines. Patients who are MRD-positive after concurrent chemoradiotherapy and have no prior exposure to immune checkpoint inhibitors are screened and enrolled to receive the investigational treatment regimen. Changes in the counts and functional activity of peripheral blood lymphocyte subsets are then evaluated. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jun Zhao | Contact | 13521469355 | ohjerry@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Jun Zhao | Peking University Cancer Hospital & Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Cancer Hospital & Institute | Beijing | China |
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| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| C553458 | apatinib |
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MRD-positive subjects will receive treatment with adebrelimab (anti-PD-L1) combined with apatinib (anti-angiogenic therapy),with close monitoring for disease progression.
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| Apatinib Mesylate Tablets | Drug | Apatinib Mesylate Tablets (250 mg, QD) , followed by ctDNA monitoring every 2 months (Year 1) and every 3 months (Year 2).The above treatment regimen will be maintained until disease progression, intolerable toxicity, completion of two years of treatment, subject-initiated withdrawal, or investigator-determined discontinuation. |
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| OS | Overall Survival (OS) is defined as the time interval from randomization (or treatment initiation in single-arm studies) to death from any cause. | Imaging assessments are performed every 3 months. After each assessment, treatment response is evaluated by senior experts according to the Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1. The maximum follow-up duration is 2 years. |
| Time to conversion to MRD negativity | Patients with limited-stage small cell lung cancer (LS-SCLC) receive concurrent chemoradiotherapy in accordance with standard diagnostic and treatment guidelines. Patients who are MRD-positive after concurrent chemoradiotherapy and have no prior exposure to immune checkpoint inhibitors are screened and enrolled to receive the investigational treatment regimen. The time required for MRD conversion from positive to negative following treatment is calculated, measured in days. | MRD is assessed at 60-day intervals during the first year and 90-day intervals during the second year, until disease progression, study discontinuation for any reason, or completion of 2 years of follow-up, whichever occurs first. |
| Duration of negative conversion after medication in MRD-positive patients | Patients with limited-stage small cell lung cancer (LS-SCLC) receive concurrent chemoradiotherapy in accordance with standard diagnostic and treatment guidelines. Patients who are MRD-positive after concurrent chemoradiotherapy and have no prior exposure to immune checkpoint inhibitors are screened and enrolled to receive the investigational treatment regimen. The duration of MRD negativity after treatment-defined as the time from conversion to MRD-negative status to subsequent reversion to MRD-positive status, if applicable-is calculated and measured in days. | MRD is assessed at 60-day intervals during the first year and 90-day intervals during the second year, until disease progression, study discontinuation for any reason, or completion of 2 years of follow-up, whichever occurs first. |
| It is assessed at 60-day intervals during the first year and 90-day intervals during the second year, until disease progression, study discontinuation for any reason, or completion of 2 years of follow-up, whichever occurs first. |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |