Actively Recruiting
Irinotecan Liposome Combined With Anlotinib as Second-line Regimen for SCLC
Led by Fudan University · Updated on 2025-08-20
39
Participants Needed
1
Research Sites
141 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Irinotecan Liposome Combined With Anlotinib as Second-line Regimen for SCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 75 years old
- Histologically or cytologically confirmed small cell lung cancer
- At least one measurable lesion according to RECIST 1.1 criteria
- Recurrence or progression confirmed by imaging within 6 months after platinum-based first-line chemotherapy or chemoradiation
- ECOG performance status score of 0 to 2
- Expected survival of more than 3 months
- Recovered from prior treatments to no more than Grade 1 toxicity or baseline, except alopecia or other non-safety concerns
- Adequate major organ function including bone marrow, liver, kidney, coagulation, and urine protein within specified limits
- Patients fully understand and agree to participate in the study
You will not qualify if you...
- Large cell neuroendocrine lung carcinoma or combined small cell lung carcinoma
- Asymptomatic central nervous system metastases or CNS disease needing increased steroid dose (controlled CNS metastasis allowed)
- Uncontrolled pleural, abdominal, or pericardial effusions after recent treatment or judged unsuitable by clinicians
- Diagnosis of any other cancer within past 5 years except cured basal cell carcinoma or in situ cancer
- Prior treatment with irinotecan, liposomal irinotecan, anlotinib, bevacizumab, or other anti-angiogenic drugs
- Use of strong CYP3A4 inducers or inhibitors or strong UGT1A1 inhibitors near study start
- Other anti-tumor treatments within 4 weeks before first dose
- Uncontrolled systemic diseases including unstable angina, myocardial infarction, congestive heart failure, severe arrhythmia
- Severe pulmonary disease within 6 months prior to enrollment
- Arterial or venous thrombosis within 6 months prior to enrollment
- Bleeding symptoms or tendency within 3 months prior to screening
- Major surgery within 4 weeks before dosing or planned during study
- Unhealed wounds, ulcers, or fractures
- Tumors involving major blood vessels with risk of fatal hemorrhage
- Active uncontrolled infections requiring systemic treatment
- Active hepatitis B or C, or HIV infection
- Known allergy or intolerance to study drugs or excipients
- Significant gastrointestinal disorders including hepatic disorders, bleeding, inflammation, occlusion, or diarrhea greater than grade 1
- Pregnant or breastfeeding
- Deemed unsuitable for the study by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Cancer hospital Fudan University
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
J
Jialei Wang, Doctor
CONTACT
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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