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Clinical Trials in China / NCT07357532
Starting soon Phase 2

Exploration of Treatment Strategies After Concurrent Chemoradiotherapy for LS-SCLC Guided by MRD

NCT07357532 · tracked via the Priya Life Science China tracker
Sponsor
Peking University Cancer Hospital & Institute
Phase
Phase 2
Started
2026-01-31
Last updated
2026-01-22

Condition(s) studied

Small Cell Lung Carcinoma

Investigational drug(s) / intervention(s)

Adebrelimab InjectionApatinib Mesylate Tablets

Adebrelimab Injection: 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.

Apatinib Mesylate Tablets: 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.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: 1. Signed informed consent; age \>18 and \<80 years; 2. Histologically or cytologically confirmed limited-stage small cell lung cancer (LS-SCLC); 3. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0-1; 4. Patients who have achieved disease stabilization after concurrent or sequential chemoradiotherapy; 5. Patients who had not received previous immune checkpoint inhibitor treatment; 6. Patients with MRD-positive status following concurrent chemoradiotherapy; 7. Willingness to provide clinical-pathological data, imaging studies, and other required materials for research purposes; compliance with follow-up procedures, including blood sample collection at predefined efficacy evaluation timepoints; and agreement to use the collected data for subsequent research analyses. Exclusion Criteria: 1. Have other malignant tumors; 2. Autoimmune disorders that are not amenable to PD-L1 inhibitor therapy; 3. Prior exposure to other anti-angiogenic small molecule TKIs such as erlotinib or anti-angiogenic monoclonal antibodies such as bevacizumab (except locally infused bevacizumab); or participation in a clinical trial of another antineoplastic agent within 4 weeks prior to the first dose of ; or prior treatment with a paclitaxel; 4. Uncontrolled hypertension (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg despite optimal pharmacologic therapy); 5. Class II or greater myocardial ischemia or myocardial infarction, poorly controlled arrhythmias (including QTc intervals ≥450 ms in men and ≥470 ms in women). According to NYHA criteria, grade III-IV cardiac insufficiency, or cardiac color ultrasound suggests that the left ventricular ejection fraction (LVEF) is \<50% have had a myocardial infarction within 6 months prior to enrollment, New York Heart Association class II or higher heart failure, uncontrolled angina pectoris, uncontrolled severe ventricular arrhythmia, clinically significant pericardial disease, or ECG suggestive of acute ischemia or active conduction system abnormalities; (6) uncontrolled angina pectoris, uncontrolled severe ventricular arrhythmias, clinically significant pericardial disease, or ECG suggestive of acute ischemia or active conduction system abnormalities. 6. Uncontrolled co-morbidities including, but not limited to, poorly controlled diabetes mellitus, diabetic peripheral lesions , persistent infections, or psychiatric or social conditions that may interfere with the subject's ability to comply; 7. Abnormal coagulation (INR \> 1.5 or Prothrombin Time (PT) \> ULN + 4 seconds or APTT \> 1.5 ULN), hemorrhagic symptoms, or on thrombolytic or anticoagulant therapy; 8. Known hereditary or acquired bleeding and thrombotic disorders such as hemophilia, coagulation disorders, thrombocytopenia, hypersplenism, etc.; 9. Significant coughing up of fresh blood or hemoptysis of one-half teaspoon (2.5 ml) per day or more within 2 months prior to entry into the study ; 10. Failure to receive specified treatment or change in treatment regimen prior to disease progression; 11. Unable to cooperate with the study in accordance with the established clinical follow-up period; 12. Unable to accept or provide the specified means of efficacy assessment such as imaging. 13. Pregnant or lactating women.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Peking University Cancer Hospital & Institute Beijing China

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07357532 on ClinicalTrials.gov ↗ ← All trials in China