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

Sponsor
China Medical University, China
Study ID
NCT07376499
Phase
PHASE2
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Liposome Irinotecan — DRUG
    Liposome irinotecan(50mg/m\^2) will be administered by intravenous infusion on day 1 in a 3-week treatment cycle
  • Platinum — DRUG
    Carboplatin (AUC 4-5) or Cisplatin (60mg/m\^2) will be administered by intravenous infusion on day 1 in a 3 week treatment cycle
  • Anlotinib — 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
  • Toripalimab — DRUG
    Toripalimab (240mg) will be administered by intravenous infusion on day 1 in a 3-week treatment cycle

Study Details

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

Key Dates

Start date
Jan 25, 2026
Status verified
Apr 2025
Primary completion
Mar 31, 2026
Completion
Jun 30, 2027

Study Design

Enrollment
31 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: treatment group
    Irinotecan hydrochloride liposome injection combined with platinum and tislelizumab therapy in a 3-week treatment cycle , 4 cycles

Primary Outcome Measure

Progression-free survival (PFS) To evaluate the efficacy of anti-tumor [ Time Frame: baseline up to approximately 6 months ]

Related Studies