Actively Recruiting
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
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a treatment approach for adults with newly diagnosed limited-stage small cell lung cancer that can be surgically removed (stage T1-3N0-1M0). This phase II clinical study explores the use of adebrelimab combined with chemotherapy and apatinib mesylate before surgery, followed by additional therapy after surgery based on individual patient assessments. The study also recommends specific radiotherapy for certain patients depending on disease stage before and after surgery. Participants receive four cycles of adebrelimab at 1200 mg every three weeks along with chemotherapy including etoposide and carboplatin every three weeks for four cycles. Concurrently, apatinib mesylate is given orally three times a week for three cycles. Surgery is scheduled within four to eight weeks after completing these treatments, with apatinib stopped four weeks prior to surgery. After surgery, treatment with adebrelimab and apatinib, with or without radiotherapy, starts four weeks later, guided by a multidisciplinary team’s recommendations. During the study, participants undergo regular evaluations including tumor assessments according to RECIST 1.1 criteria. Researchers track event-free survival over two years as the primary outcome, along with other measures such as major pathological response, overall survival, objective response rate, treatment side effects, and pathological complete response. Safety, tolerability, and treatment effects are monitored throughout up to two years, with detailed follow-up to assess the impact of the combined therapies.
CONDITIONS
Brief 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 must be assessed and confirmed as surgically removable by a surgeon, radiation oncologist, and radiologist
- Must have measurable target lesions according to RECIST 1.1 criteria
- ECOG performance status score of 0 or 1
- No history of other malignancies
- No prior surgery, radiotherapy, chemotherapy, immunotherapy, or other anti-tumor treatments for small cell lung cancer
- Adequate cardiopulmonary function and ability to tolerate surgery as assessed by a surgeon
- Bone marrow, coagulation, liver, and kidney function must meet specified laboratory thresholds
- Males with reproductive potential and women of childbearing age must agree to use effective contraception during and for 180 days after treatment
- Voluntary participation with signed informed consent
You will not qualify if you...
- Inability to completely remove all cancer lesions through 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 including HIV, active hepatitis B or C
- Presence of large uncontrollable fluid buildup such as pleural effusion or ascites
- Need for systemic corticosteroids or immunosuppressants within 14 days before treatment
- Recent treatment with anti-tumor vaccines or immunostimulatory drugs within 1 month
- Participation in other interventional clinical studies
- Evidence of severe lung disease or impaired lung function
- Severe heart disease or recent heart attack
- 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 those unwilling to use contraception
- Known allergies or intolerance to study drugs
- Uncontrolled hypertension
- Abnormal blood clotting or bleeding tendencies
- Recent arterial or venous blood clots
- Known bleeding or clotting disorders
- Any condition deemed unsuitable by the researcher for study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 4 to 8 weeks for initial treatment plus additional treatment starting 4 weeks post-surgery
Participants receive Adebrelimab intravenously every 3 weeks for 4 cycles, Apatinib mesylate orally three times per week for 3 cycles concurrent with Adebrelimab, and platinum-based chemotherapy with Etoposide and Carboplatin every 3 weeks for 4 cycles. Surgery is performed within 4 to 8 weeks after treatment. After surgery, participants may receive additional Adebrelimab and Apatinib mesylate treatment, with or without radiotherapy, based on medical assessment.
Regular visits every 3 weeks during treatment cycles and follow-up visits after surgery
Duration - Up to 2 years
Participants are monitored for up to 2 years for event-free survival, overall survival, treatment response, and adverse events.
Periodic visits during follow-up for assessments
Trial Site Locations
Total: 1 location
1
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Actively Recruiting
Research Team
Y
Ying Jin, MD&PhD
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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