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NENSPhase 2NCT07077551

NALIRIFOX as Second-Line Chemotherapy in Extrapulmonary High-grade Neuroendocrine Neoplasms: a Prospective, Single-center, Single-arm Trial

A Phase 2 study testing NALIRIFOX in people with NENS, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
NENS
What is being tested?
NALIRIFOX
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
1 siteChina
Study dates
22 Apr 2025to 31 Dec 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Provide written Informed Consent Form to voluntarily enroll in this study.
  • Men or women aged 18-75.
  • Histologically or cytologically confirmed metastatic neuroendocrine carcinoma, neuroendocrine tumour G3 or mixed neuroendocrine-non-neuroendocrine tumour (neuroendocrine component >30%)
  • Patients who have failed one previous systemic treatment.
  • ECOG PS score of 0 or 1.
  • Life expectancy is at least 3 months.
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  • The investigator assessed the presence of measurable lesions at baseline by imaging (according to RECIST 1.1), and measurable lesions should not have received local treatment such as radiotherapy (lesions located within the area of previous radiotherapy may also be selected as target lesions if progression is confirmed to have occurred).
  • Function of vital organs in accordance with the following requirements (no blood components, cell growth factor corrective therapy with any medication is permitted within 14 days prior to the first use of the study drug); ① Absolute neutrophil count (ANC) ≥1.5×109/L
  • ② Platelets ≥ 100 x 109/L;
  • ③ Haemoglobin ≥ 8g/dL;
  • ④ Total bilirubin ≤ 1.5 × ULN; ALT, AST ≤ 2.5 × ULN, and if liver metastases are present, ALT, AST ≤ 5 × ULN;
  • ⑤ Serum creatinine ≤ 1.5 × ULN or creatinine clearance > 60 mL/min (Cockcroft-Gault);
  • Female subjects of childbearing potential are required to have a negative serum pregnancy test within 72 hours prior to initiation of trial drug administration and to use effective contraception (e.g., IUD, birth control pills, or condoms) during the trial period and for at least 3 months after the last dose; male subjects whose partner is a female of childbearing potential are required to use effective contraception during the trial period and for at least 3 months after the last dose. For male subjects whose partners are women of childbearing potential

Who cannot join

  • Known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects who have been previously treated for brain metastases may participate in treatment provided they have stable brain metastases and have not been treated for brain metastases with steroids for at least 28 days prior to study entry. This exception does not include carcinomatous meningitis, as patients with carcinomatous meningitis are excluded regardless of clinical stability;
  • Major surgery, open biopsy or severe trauma 28 days prior to first dose;
  • Prior history of allergy to fluorouracil or irinotecan;
  • Have high blood pressure that is not well controlled by antihypertensive medication (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg)
  • Subjects with uncontrolled cardiovascular clinical conditions or disease, including but not limited to: e.g., (1) NYHA class II or higher heart failure (2) unstable angina (3) myocardial infarction within 1 year (4) clinically significant supraventricular or ventricular arrhythmia not controlled without or with clinical intervention
  • Have experienced clinically significant bleeding symptoms or have a definite tendency to bleed within 3 months prior to the first dose, e.g. peptic haemorrhage, haemorrhagic gastric ulcer or have vasculitis;
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  • Arterial/venous thrombotic events such as cerebrovascular accidents (including temporary ischaemic attack, cerebral haemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism occurring within 6 months prior to the first dose of the drug, with superficial vein thrombosis being eligible for enrolment as determined by the investigator; and
  • There is another malignancy that is progressing or requires active treatment, with the exception of non-melanoma skin cancers and cervical cancer in situ for which potential treatment has already been undertaken;
  • Women who are pregnant or breastfeeding;
  • In the judgement of the investigator, the subject has other factors that may cause him/her to be forced to terminate the study midway, such as other serious illnesses (including psychiatric illnesses) that require comorbid treatment, severely abnormal laboratory test values, family or social factors that may affect the subject's safety or the collection of experimental data

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site, 1 recruiting

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

    Hangzhou, Zhejiang

    Wen Cai, 8618258203041, caiwen@zju.edu.cn

    Recruiting

Other trials in China

About this study

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
NENS
Being tested
NALIRIFOX

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NALIRIFOXDrug

    A cycle will be repeated every 14 days. G-CSF prophylaxis will be allowed after each cycle. Patients will undergo re-staging studies every 8 weeks. Patients will receive up to 12 cycles during the study. Additional cycles will be determined per investigators' discretion.

Study groups in NCT07077551
Study groupRoleWhat they receive
NALIRIFOXExperimentalNALIRIFOX
Receives: Drug: NALIRIFOX

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 6-month Progression-Free Survival

    Measured: Through study completion, an average of 1 year

Secondary outcomes (4)

  1. Objective Response Rate

    Measured: 1 year

  2. Disease Control Rate

    Measured: 1 year

  3. Overall Survival

    Measured: 1 year

  4. Quality of Life (QoL) assessment

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jul 2025
  2. Study start22 Apr 2025
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
28 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07077551
Sponsor's protocol ID
2025-0428
Status last verified
Apr 2025
First submitted
27 Jun 2025
Last updated
22 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing NALIRIFOX in people with NENS, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

6-month Progression-Free Survival (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07077551.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2025.

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