Advanced extrapulmonary neuroendocrine carcinoma
Conditions
Interventions
Irinotecan liposome combined with anlotinib treatment group:Irinotecan liposome, Anlotinib
Sponsors
Jiangsu Provincial Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18–75 years; 2. Patients with histopathologically confirmed advanced extrapulmonary neuroendocrine carcinoma (including locally advanced and metastatic EP-NEC); 3. Patients with EP-NEC who have previously failed first-line platinum-based chemotherapy (imaging-confirmed disease progression) or experienced intolerable toxicity; for patients receiving neoadjuvant or adjuvant therapy, disease recurrence during treatment or within 6 months of the last treatment is considered first-line treatment failure; 4. At least one measurable lesion according to RECIST 1.1 for solid tumours; 5. ECOG performance status 0–1; 6. Expected survival >=3 months; 7. Possess adequate organ function, with haematological and biochemical blood tests completed within 14 days prior to enrolment, and meet the following criteria: a. Absolute neutrophil count (ANC)>= 1.5 × 10^9/L; b. Haemoglobin >= 90 g/dL; c. Platelets (PLT) >= 100 × 10^9/L; d. Total bilirubin =60 mL/min, with negative urine protein. For patients with baseline urine protein >= 2+, a 24-hour urine collection must be performed, demonstrating protein excretion < 1 g within 24 hours; 8. Patients with brain metastases must meet the following criteria: (1) No clinical symptoms related to brain metastases, no requirement for systemic corticosteroids or anticonvulsant therapy; (2) No risk of intracranial haemorrhage; 9. Male subjects, women of childbearing potential, and their partners must voluntarily use effective contraceptive measures deemed appropriate by the investigator during treatment and for at least three months after the last dose of study medication. 10.Able to understand and voluntarily sign a written informed consent form, which must be obtained prior to any study-specific procedures.
Exclusion criteria
Exclusion criteria: 1. Previous treatment with anti-vascular endothelial growth factor (VEGF)/vascular endothelial growth factor receptor (VEGFR) targeted therapy; 2. Previous treatment with irinotecan or irinotecan liposome; 3. Receipt of biological therapy, chemotherapy, surgery, radiotherapy (56 days for PRRT), immunotherapy, or other investigational medicinal products (excluding placebo) within 28 days prior to the first dose of study drug; or receipt of small-molecule therapy within 5 half-lives (e.g., 6 days for everolimus, 10 days for sunitinib); 4. Adverse events (excluding alopecia) from prior antineoplastic therapy remain unresolved (grade higher than I per CTCAE version 5.0); 5. Known active, uncontrolled, or symptomatic central nervous system metastases, carcinomatous meningitis, or clinically symptomatic leptomeningeal disease, cerebral oedema, and/or progressive tumour growth. Patients with a history of CNS metastases or spinal cord compression may be eligible for inclusion if they have received definitive local treatment (e.g., radiotherapy, stereotactic surgery) and are clinically stable, provided anticonvulsants and steroids have been discontinued for at least 4 weeks prior to enrolment; 6. Known bleeding diathesis or disease; 7. Patients with any severe and/or uncontrolled medical condition: a. Unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction within 6 months, severe uncontrolled arrhythmia; b. Active or uncontrolled severe infection; c. Liver disease such as cirrhosis, decompensated liver disease, chronic hepatitis (i.e. quantifiable HBV-DNA and/or HBsAg positive, quantifiable HCV-RNA); d. Known severe pulmonary impairment (pulmonary function tests and DLCO at 50% or less of normal values, oxygen saturation at rest in room air conditions of 88% or below); 8. Uncontrolled hypertension defined as systolic blood pressure >=140 mmHg and/or diastolic blood pressure >=90 mmHg; 9. Active gastrointestinal bleeding from prior or current gastric/duodenal ulcers, ulcerative colitis, or unresected gastrointestinal tumours; or other conditions deemed by the investigator likely to cause gastrointestinal haemorrhage or perforation; 10. Severe diarrhoea (Grade 2 or higher per NCI-CTCAE 5.0 criteria: increase in stool frequency to >=4 times daily compared to baseline; marked increase in stoma output; limitation in activities of daily living); 11. History of deep vein thrombosis, pulmonary embolism, or other severe thromboembolic events within 6 months prior to first study drug administration; 12. Subjects with major trauma, non-healing wounds, or unhealed fractures; 13. Subjects with uncontrolled systemic diseases (e.g., cardiovascular conditions such as unstable angina, myocardial infarction, congestive heart failure, history of severe unstable ventricular arrhythmias, or severe pericardial disease; uncontrolled hypertension, diabetes mellitus, etc.); 14. Known allergy or intolerance to the study drug or its excipients; 15. Patients concurrently participating in other interventional clinical studies; 16. Patients requiring treatment for other concurrent malignancies; 17. Patients deemed unsuitable for this study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival, PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of relief,DOR;Overall survival, OS;Disease control rate, DCR;Objective response rate, ORR;Security; | — |
Countries
China
Contacts
Public ContactChen Linxiang
Jiangsu Provincial Cancer institute (Jiangsu Provincial Tumor Hospital)
Outcome results
None listed