Actively Recruiting
A Study of Adebrelimab Combined With Apatinib Mesylate and Chemotherapy for Neoadjuvant Therapy and Biomarker Analysis in Limited-stage Small Cell Lung Cancer
Led by Jin Ying · Updated on 2025-04-15
38
Participants Needed
1
Research Sites
131 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a single-arm, prospective, exploratory phase II clinical study. The study enrolled newly diagnosed stage T1-3N0-1M0 resectable limited-stage small cell lung cancer. Adebrelimab combined with chemotherapy for 4 cycles and apatinib mesylate for 3 cycles. Surgery was performed within 4-8 weeks after the above treatment (the operation was performed 4 weeks after apatinib was discontinued). According to the results of MDT discussion, adebrelimab combined with apatinib mesylate combined with or without radiotherapy was started 4 weeks after surgery. Preoperative prophylactic radiotherapy (PCI) is recommended for patients with preoperative stage N1. Patients with postoperative stage N1 received postoperative thoracic radiotherapy.
CONDITIONS
Official Title
A Study of Adebrelimab Combined With Apatinib Mesylate and Chemotherapy for Neoadjuvant Therapy and Biomarker Analysis in Limited-stage Small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years old
- Histologically or cytologically confirmed limited-stage small cell lung cancer (T1-3N0-1M0)
- All lesions confirmed resectable by surgeon, radiation oncologist, and radiologist
- Measurable target lesions per RECIST 1.1 criteria
- ECOG performance status score of 0-1
- No history of other malignancies
- No prior treatment for small cell lung cancer including surgery, radiotherapy, chemotherapy, or immunotherapy
- Adequate cardiopulmonary function: FEV1 and DLCO 50% predicted, LVEF 55%, no heart failure or severe coronary artery disease
- Adequate organ function: bone marrow, coagulation, liver, and kidney within specified limits
- Males with reproductive capacity and women of childbearing age must agree to use effective contraception until 180 days after last study drug
- Negative pregnancy test within 7 days before first study drug administration
- Voluntary informed consent to participate in the study
You will not qualify if you...
- Inability to completely remove all lesions by surgery
- Prior anti-tumor treatment for small cell lung cancer
- Previous use of immunocheckpoint inhibitors such as PD-1/PD-L1 inhibitors
- History of active autoimmune diseases or immune system deficiencies
- Active hepatitis B or C infection, or HIV infection
- Uncontrolled pleural effusion, ascites, or pericardial effusion
- Systemic corticosteroid or immunosuppressant use within 14 days before first drug administration (except inhaled/topical corticosteroids)
- Treatment with anti-tumor vaccines or immunostimulatory drugs within 1 month before first drug administration
- Participation in other interventional clinical studies
- Lung diseases such as pulmonary fibrosis or severe lung function impairment
- Severe heart disease or recent myocardial infarction
- Major surgery, open biopsy, or significant trauma within 28 days before enrollment
- History of allogeneic organ or stem cell transplantation
- Pregnant or breastfeeding women or unwillingness to use contraception
- Known allergic reactions or intolerance to study drugs
- Uncontrolled hypertension
- Abnormal coagulation or bleeding disorders
- Recent significant bleeding or thrombotic events
- Genetic or acquired bleeding/thrombotic tendencies
- Other conditions judged unsuitable by the investigator
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Trial Site Locations
Total: 1 location
1
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Actively Recruiting
Research Team
Y
Ying Jin, MD&PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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