Irinotecan Liposome Combined With Anlotinib as Second-line Regimen for SCLC

Sponsor
Fudan University
Study ID
NCT06258642
Status
Recruiting
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Conditions

  • Small Cell Lung Cancer Recurrent

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Irinotecan Liposome — DRUG
    70 mg/m\^2 , d1, Q2W, iv
  • Anlotinib — DRUG
    12 mg, qd, po for 2 consecutive weeks and then discontinued for 1 week.

Study Details

This study is a single arm, multi-center, prospective clinical trial. The purpose of this study is to evaluate the efficacy and safety of liposomal irinotecan combined with anlotinib hydrochloride for relapsed small-cell lung cancer, who have progressed on or less than 6 month after platinum-based first-line therapy.

Key Dates

Start date
Apr 17, 2024
Status verified
Aug 2025
Primary completion
Apr 30, 2026
Completion
Dec 31, 2026

Study Design

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

Arms

  • Experimental: Irinotecan Liposome and anlotinib
    The treatment is continued until disease progression or intolerable toxicity

Primary Outcome Measure

Objective response rate（ORR） [ Time Frame: From date of first dose until the date of first documented progression, assessed up to 24 months ]

Central Contacts