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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Irinotecan Liposome
Drug70 mg/m\^2 , d1, Q2W, iv
Anlotinib
Drug12 mg, qd, po for 2 consecutive weeks and then discontinued for 1 week.
Treatment groups
39 Participants
are divided into 1 treatment groupGroup A: Irinotecan Liposome and anlotinibExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Objective response rate（ORR）
To evaluate anti-tumor efficacy
Time frame
From date of first dose until the date of first documented progression, assessed up to 24 monthsSecondary outcomes
1
Disease control rate (DCR)
To evaluate anti-tumor efficacy
Time frame
From date of first dose until the date of first documented progression, assessed up to 24 months2
Duration of Response(DoR)
To evaluate anti-tumor efficacy
Time frame
From date of first dose until the date of first documented progression, assessed up to 24 months3
Progression-Free Survival (PFS)
To evaluate anti-tumor efficacy
Time frame
From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months4
Overall Survival (OS)
To evaluate anti-tumor efficacy
Time frame
From date of first dose until the date of death from any cause , assessed up to 24 monthsSponsors and contacts
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Source ClinicalTrials.gov