Actively Recruiting
Study of Liposomal Irinotecan Combined with Apatinib for Extensive Stage Small Cell Lung Cancer After First-line Treatment Progression
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2024-12-27
30
Participants Needed
1
Research Sites
152 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of combining liposomal irinotecan with apatinib to treat patients with extensive stage small cell lung cancer (ES-SCLC) that has progressed after first-line treatment. This phase 2 study addresses the challenge that most patients experience disease progression after initial therapies, aiming to improve survival and quality of life. Liposomal irinotecan is designed to improve drug delivery and reduce toxicity, while apatinib blocks blood vessel growth to tumors, and their combination may enhance anti-tumor effects. Participants will receive treatment with liposomal irinotecan combined with apatinib. The study focuses on patients who have measurable tumors and have failed first- or second-line treatments. The combination is expected to provide synergistic effects by combining chemotherapy with anti-angiogenic therapy, which has shown promise in various cancers including SCLC. During the study, researchers will monitor the progression-free survival rate at 6 months from enrollment. Participants will undergo assessments to evaluate tumor response and safety throughout the treatment period. The study includes patients aged 18 to 75 years with an expected survival of at least 12 weeks. Monitoring will ensure the treatment's effects and side effects are carefully evaluated.
CONDITIONS
Official Title
Liposomal Irinotecan and Apatinib in ES-SCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years
- Expected survival of at least 12 weeks
- At least one measurable tumor lesion according to RECIST version 1.1
- Have failed first-line or second-line treatment for small cell lung cancer
You will not qualify if you...
- Previous treatment with systemic drugs targeting VEGF or VEGFR, such as ranibizumab, fipronib, apatinib, anlotinib, lenvatinib, sunitinib, or sorafenib
- Active or uncontrolled severe infection with CTCAE grade 2 or higher, or antibiotic treatment within 2 weeks before enrollment
- Conditions that affect oral medication absorption, including inability to swallow, nausea, vomiting, chronic diarrhea, or intestinal obstruction
- Considered unsuitable for the study by the doctors
AI-Screening
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Trial Site Locations
Total: 1 location
1
Second Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, China, 310009
Actively Recruiting
Research Team
X
Xian Zhong
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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