Study on the Therapeutic Effect of Irinotecan Liposomes in Small Cell Lung Cancer

Sponsor
Tang-Du Hospital
Study ID
NCT06467786
Phase
PHASE4
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

Study Details

This study is a prospective, multicenter, single arm Phase II exploratory study. It is expected to include 24 first-line patients with small cell lung cancer who have progressed after 6 months of treatment with platinum containing regimens, and receive treatment with irinotecan liposomes combined with cisplatin or carboplatin regimens.

Key Dates

Start date
Mar 15, 2024
Status verified
Jun 2024
Primary completion
Sep 15, 2025
Completion
Sep 15, 2028

Study Design

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

Arms

  • Experimental: Experimental administration group
    Irinotecan hydrochloride liposome injection: 70mg/m2, intravenous infusion CISPLATIN: 60mg/m2, intravenous infusion or carboplatin: AUC=5, intravenous infusion

Primary Outcome Measure

Intracranial Objective response rate [ Time Frame: Data obtained up until progression, or the last evaluable assessment in the absence of progression, will be assessed up to 1 years. ]

Central Contacts

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