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

Launched by FUDAN UNIVERSITY · Feb 6, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment approach for patients with recurrent small cell lung cancer (SCLC), which is a type of lung cancer that can come back after initial treatment. The study is testing the effectiveness and safety of a combination of two medications: liposomal irinotecan and anlotinib. This trial is aimed at adults aged 18 to 75 who have experienced a return of their cancer within six months after receiving first-line chemotherapy or radiation therapy. Participants must have measurable cancer lesions, meaning there are visible signs of cancer that can be tracked, and they should have a good overall health status to ensure they can tolerate the treatment.

Patients who join this study can expect to receive the combination treatment and will be monitored closely for any side effects and how well the treatment is working. However, there are certain criteria that could prevent someone from participating, such as having other significant health issues or previous treatments that might interfere with the study. The trial is not yet recruiting participants, but it aims to provide new hope for those dealing with this challenging condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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;
• • 5) Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2;
• • 6) Expected survival of more than 3 months;
• • 7) Recovered from the effects of any prior chemotherapy, surgery, radiotherapy or other anti-neoplastic therapy (recovered to no more than Grade 1 of CTCAE 5.0 criteria or baseline, with the exception of alopecia or other toxicity without safety concerns by the investigators' judgment);
• * 8) Adequate major organ function, patients should meet the following criteria:
• • ① Bone marrow function: absolute neutrophile count (ANC)≥1.5×109/L，platelet (PLT)≥100×109/L, hemoglobin (Hb)≥90g/L, white blood cell (WBC)≥3.0×109/L；
• • ② Hepatic function: total bilirubin≤1.5×upper limit of normal value(ULN)；ALT and AST≤2.5×ULN，liver metastasis：≤5×ULN；
• • ③ Renal function: serum creatinine ≤1.5×ULN and creatinine clearance rate ≥60 mL/min;
• • ④ Coagulation function：Activated partial thromboplastin time(APTT)、International normalized ratio(INR)、prothrombin time (PT)≤1.5×ULN；
• • ⑤ urine routines show urine protein \< 2+(when urine protein \>2+, urine protein quantity\< 1.0 g during 24 hours before 7 days);
• • 9) Patients fully understood and volunteered to participate in the study.
• Exclusion Criteria:
• • 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);
• • 5) Patients who have received prior irinotecan/ liposomal irinotecan and anti-angiogenic drugs such as anlotinib and bevacizumab , etc.
• • 6) Concomitant use of strong CYP3A4 inducers within 2 weeks or strong CYP3A4 inhibitors or strong UGT1A1 inhibitors within 1 week of the first dose of the study drug;
• • 7) Patients who have received other anti-tumor treatments(including radiotherapy, chemotherapy, immunotherapy, etc.) within 4 weeks before the first dose;
• • 8) Combined with uncontrolled systemic diseases, including unstable angina, myocardial infarction, congestive heart failure, severe ventricular arrhythmia , etc.
• • 9) Severe pulmonary disease within 6 months prior to enrolment, such as interstitial pneumonia, pulmonary fibrosis, radiation induced pneumonitis requiring steroid therapy, and other moderate and severe lung diseases which affect lung function;
• • 10) Arterial/venous thrombosis within 6 months prior to enrollment, e.g. cerebrovascular accident (include temporary ischemic attack), deep venous thrombosis, pulmonary embolism.
• • 11) Symptoms or propensity to bleed within 3 months prior to screening (include gastrointestinal hemorrhage, ulcerative gastric bleeding, fecal occult blood 2+ or above, vasculitis);
• • 12) Patients had undergone major surgical procedure(except for diagnostic surgery) within 4 weeks before dosing or was scheduled to receive major procedure during the study;
• • 13) unhealed wounds, ulcers or fractures;
• • 14) Imaging showed tumors have involved important blood vessels or by investigators determine likely during the follow-up study and cause fatal hemorrhage;
• • 15) Active and uncontrolled bacterial, viral, fungal infection requiring systemic treatment;
• • 16) Active hepatitis B/C, or HIV infection;
• • 17) Known intolerance or allergy to therapeutic drugs and their excipients;
• • 18) Clinically significant gastrointestinal disorder, including hepatic disorders, bleeding, inflammation, occlusion, or diarrhea \> grade 1;
• • 19) Pregnant or breast feeding;
• • 20) Patient is not suitable for the study in the investigator's opinion.