Actively Recruiting
Study of Liposomal Irinotecan Combined with Apatinib in the Treatment of Extensive Stage Small Cell Lung Cancer After First-line Progression
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2024-12-27
30
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to assess the effectiveness and safety of combining liposomal irinotecan with apatinib in treating extensive stage small cell lung cancer (SCLC) that has progressed after first-line treatment. Extensive stage SCLC is a highly aggressive cancer with rapid growth, and while initial treatments like etoposide with platinum and immunotherapy are often effective, many patients experience disease progression. Current second-line treatments offer limited success, making new combination therapies important to explore. Participants will receive a combination of liposomal irinotecan, a chemotherapy drug designed to improve stability and target tumors effectively, and apatinib, a drug that blocks blood vessel growth to tumors. This combination is being studied because it may work together to better fight the cancer. The study evaluates this treatment in patients who have failed first-line or second-line therapies, focusing on the safety and anti-tumor effects of the combined drugs. During the study, participants will be monitored for progression-free survival at six months as the primary outcome. Additional measures include response rates, progression-free survival duration, and overall survival. Assessments will include imaging to measure tumors, safety evaluations, and ongoing monitoring throughout treatment and follow-up. The trial lasts until the end of life or specified time points to gather comprehensive data on treatment impact and safety.
CONDITIONS
Brief 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 criteria
- Disease progressed after first-line or second-line treatment
You will not qualify if you...
- Previous treatment with drugs targeting VEGF or VEGFR such as apatinib or similar agents
- Active or uncontrolled severe infection or recent antibiotic treatment within 2 weeks
- Conditions that affect swallowing or absorption of oral medication like nausea, vomiting, chronic diarrhea, or intestinal blockage
- Deemed unsuitable for inclusion by doctors
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 - 6 to 8 weeks
Participants receive liposomal irinotecan combined with apatinib as a treatment for extensive stage small cell lung cancer after progression on first-line therapy.
Weekly visits for up to 8 weeks
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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