Irinotecan Liposome Combined With Anlotinib as Second-line Regimen for SCLC
ConditionSmall Cell Lung Cancer Recurrent
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorFudan University
About this trial
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.
Eligibility criteria
Qualifiers
1) Aged ≥18 and ≤75 years old;
2) Histologically or cytologically confirmed small cell lung cancer;
3) At least one measurable lesion according to the Response Evaluation Criteria in Solid Tumours (RECIST) 1.1;
4) Radiologically confirmed recurrence or progression within 6months after platinum-based, first-line chemotherapy or chemoradiation therapy;
Disqualifiers
1) Patients with large cell neuroendocrine lung carcinoma or combined small cell lung carcinoma;
2) Patients with asymptomatic central nervous system (CNS) metastases prior to enrollment or those who have CNS disease requiring increase in the dose of steroid. (Patients with controlled CNS metastasis can participate in the trial);
3) Patients with uncontrolled pleural effusion, abdominal effusion and pericardial effusion after repeated drainage or other treatment within 2 weeks prior to the first dose of this study, and those judged by the clinicians to be unsuitable for the study;
4) Diagnosed with any other cancer within the past 5 years (except for cured basal cell carcinoma and in situ cancer);
Trial design
Treatments tested in this trial
- Irinotecan Liposome
- Anlotinib
Treatment groups
39 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov