Actively Recruiting
NALIRIFOX as Second-Line Chemotherapy in Extrapulmonary High-grade Neuroendocrine Neoplasms: a Prospective, Single-center, Single-arm Trial
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2025-07-22
28
Participants Needed
1
Research Sites
192 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
High-grade neuroendocrine neoplasms (NENs) comprise both well-differentiated grade 3 neuroendocrine tumors (G3 NETs) and poorly differentiated neuroendocrine carcinomas (NECs). Mixed neuroendocrine-non-neuroendocrine neoplasms (MiNENs) nearly always include poorly differentiated NEC as the neuroendocrine component. Liposomal irinotecan hydrochloride and NALIRIFOX (liposomal irinotecan hydrochloride with fluorouracil and oxaliplatin) obtained a significant breakthrough in pancreatic cancer treatment. While the efficacy and safety of NALIRIFOX has never been investigated in patients with extrapulmonary high-grade NENs. Investigators conducted a two-stage, prospective, single-center, single-arm trial which enrolled patients with extrapulmonary advanced high-grade NENs who failure of first-line treatment. The primary endpoint is 6-moth disease-free survival. The second endpoint is disease control rate. Investigators will enroll 12 patients in first stage. If more than 6 patients reach 6-moth disease-free survival, the research enters the next stage. Investigators will enroll 28 patients in total, and if more than 19 patients reach the primary endpoint, investigators will further design the phase III clinical trail.
CONDITIONS
Official Title
NALIRIFOX as Second-Line Chemotherapy in Extrapulmonary High-grade Neuroendocrine Neoplasms: a Prospective, Single-center, Single-arm Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide written informed consent to participate in the study.
- Men or women aged 18 to 75 years.
- Histologically or cytologically confirmed metastatic neuroendocrine carcinoma, grade 3 neuroendocrine tumor, or mixed neuroendocrine-non-neuroendocrine tumor with neuroendocrine component greater than 30%.
- Patients who have failed one previous systemic treatment.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
- Life expectancy of at least 3 months.
- Measurable lesions present at baseline by imaging, not previously treated locally unless progression is confirmed.
- Adequate vital organ function: absolute neutrophil count ≥1.5×10^9/L; platelets ≥100×10^9/L; hemoglobin ≥8 g/dL; total bilirubin ≤1.5 times upper limit of normal (ULN); ALT and AST ≤2.5 times ULN (or ≤5 times ULN if liver metastases present); serum creatinine ≤1.5 times ULN or creatinine clearance >60 mL/min.
- Female participants of childbearing potential must have a negative pregnancy test within 72 hours before treatment and use effective contraception during the study and for at least 3 months after last dose; male participants with female partners of childbearing potential must use effective contraception during and for at least 3 months after last dose.
You will not qualify if you...
- Known active central nervous system metastases or carcinomatous meningitis; stable brain metastases treated and off steroids for at least 28 days are allowed except carcinomatous meningitis.
- Major surgery, open biopsy, or severe trauma within 28 days before first dose.
- History of allergy to fluorouracil or irinotecan.
- Poorly controlled high blood pressure (systolic ≥140 mmHg or diastolic ≥90 mmHg).
- Uncontrolled cardiovascular conditions, including NYHA class II or higher heart failure, unstable angina, recent myocardial infarction within 1 year, or significant arrhythmias.
- Recent significant bleeding or bleeding tendency within 3 months before first dose.
- Arterial or venous thrombotic events within 6 months before first dose, except superficial vein thrombosis.
- Other progressing malignancies requiring active treatment, except non-melanoma skin cancer and treated cervical cancer in situ.
- Pregnancy or breastfeeding.
- Other serious illnesses or psychiatric conditions that may require treatment or affect safety or data collection as judged by the investigator.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
Actively Recruiting
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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