Prospective, Single-arm, Phase II Clinical Study of Irinotecan Hydrochloride Liposome Injection Combined With Platinum and Immune Checkpoint Inhibitors Combined With Anlotinib for the Maintenance of Extensive Small Cell Lung Cancer After First-line Induction
NCT06951841 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 31
Last updated 2025-04-30
Summary
To evaluate the efficacy and safety of liposome irinotecan combined with platinum and immune checkpoint inhibitor combined with antirotinib maintenance therapy after first-line induction
Conditions
Interventions
- DRUG
-
Liposome Irinotecan
Liposome irinotecan(50mg/m\^2) will be administered by intravenous infusion on day 1 in a 3-week treatment cycle
- DRUG
-
Platinum
Carboplatin (AUC 4-5) or Cisplatin (60mg/m\^2) will be administered by intravenous infusion on day 1 in a 3-week treatment cycle
- DRUG
-
Tislelizumab
Tislelizumab (200mg) will be administered by intravenous infusion on day 1 in a 3-week treatment cycle
- DRUG
-
Anlotinib (8mg) will be administered orally in a 3-week treatment cycle, once a day from day 1 to day 14 of each cycle
Sponsors & Collaborators
-
China Medical University, China
lead OTHER
Principal Investigators
-
Yunpeng Liu · First Hospital of China Medical University
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-04-30
- Primary Completion
- 2026-05-31
- Completion
- 2027-06-30
Countries
- China
Study Locations
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