AzTrials
AzTrials

Neuroendocrine CarcinomaPhase 2NCT04705519

Nab-paclitaxel Combined with Bevacizumab in the Treatment of Metastatic Extrapulmonary Neuroendocrine Carcinoma

A Phase 2 study testing Nab-paclitaxel Combined With Bevacizumab in people with Neuroendocrine Carcinoma, run by Peking University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is an open-label, phase II study evaluating efficacy and safety of Nab-paclitaxel Combined With Bevacizumab for unresectable Recurrent or metastatic extrapulmonary neuroendocrine carcinoma. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Neuroendocrine Carcinoma
What is being tested?
Nab-paclitaxel Combined With Bevacizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
79 participants
Where
1 siteChina
Study dates
5 Jan 2021to 30 Sep 2024
Phase
Phase 2
Are there results?
None posted in the registry

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients who provided written informed consent to be subjects in this trial
  • Aged ≥18 years
  • Has histologically-confirmed diagnosis of locally advanced unresectable or metastatic extrapulmonary neuroendocrine carcinoma
  • Has received and progressed on ≥1 prior systemic therapy for their advanced disease.
  • Performance status of 0 to 2 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale
  • Have measurable disease as defined by RECIST 1.1 as determined by investigator assessment
Show all 10Show fewer
  • Agree to provide tumor tissue sample deemed adequate for histopathology confirmation
  • Adequate Organ Function Laboratory Values:
  • Hemoglobin ≥90g/L; Absolute neutrophil count (ANC) ≥1.5×109/L; Platelets ≥80×109/L; AST and ALT ≤ 1.5 ULN or ≤ 3 ULN for subjects with liver metastases; Total bilirubin ≤1.5 ULN; Serum creatinine ≤1.5 ULN or measured or calculated creatinine clearance > 50ml/min; Albumin ≥ 30g/L;
  • Female subjects of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to receiving the first dose of study medication and must be willing to use an adequate method of contraception for the course of the study through 90 days after the last dose of study medication. Male subjects of childbearing potential must agree to use an adequate method of contraception starting with the first dose of study therapy through 90 days after the last dose of study therapy

Who cannot join

  • Patients have recovered adverse events associated with pretreatment to Grade 1 or lower with CTCAE v5.0 excluding alopecia
  • Patients have an active malignancy (except for definitively treated basal cell carcinoma of the skin, or carcinoma-in-situ of the cervix) within the past 5 years
  • Patients with uncontrolled central nervous system metastasis
  • Received anti-tumor therapy within 4 weeks, including: chemotherapy (the washout period of oral fluorouracil drugs is 2 weeks), targeted therapy (the washout period of small molecule targeted drugs is 2 weeks or 5 half-lives, whichever is shorter), immunotherapy, etc.;
  • Received radical radiotherapy (including >25% bone marrow radiotherapy) and brain radiotherapy within 4 weeks; brachytherapy (such as implantation of radioactive particles) within 60 days; received palliative radiotherapy for bone metastases within 1 week;
  • Patients with a history of prior treatment with docetaxel, paclitaxel, nab-paclitaxel or bevacizumab
Show all 17Show fewer
  • Received surgery within 4 weeks or unhealed wounds, Ulcers, fractures;
  • Uncontrollable malignant pleural effusion, ascites, or pericardial effusion (defined as the investigator's judgment cannot be effectively controlled by diuretics or puncture);
  • Patients have gastrointestinal diseases such as active gastric and duodenal ulcers, ulcerative colitis, or active bleeding from unresected tumors, or other conditions judged that may cause gastrointestinal bleeding or perforation;
  • Patients with evidence or medical history of thrombosis or obvious bleeding tendency within 2 months (bleeding> 30 mL within 2 months, hematemesis, melena, blood in the stool), hemoptysis (> 5 mL of fresh blood within 4 weeks);
  • Patients have arterial thrombosis or deep vein thrombosis occurred within 6 months; or stroke and/or transient ischemic attack occurred within 12 months;
  • Active heart disease that is not well controlled, e.g. symptomatic coronary heart disease, New York Heart Association (NYHA) congestive heart failure of grade II or above, severe arrhythmias requiring drug intervention, myocardial infarction within the past 6 months, LVEF<50%
  • Patients judged with clinically significant electrolyte abnormalities
  • Patients have an active infection or an unexplained fever (temperature> 38.5℃) during the screening period or before the first administration
  • Patients with active tuberculosis (TB) who are receiving anti-tuberculosis treatment or have received anti-tuberculosis treatment within 1 year
  • Is pregnant or breastfeeding
  • Patients were judged unsuitable as subjects of this trial by investigators.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

Other trials in China

About this study

Official title: A Prospective, Non-randomized, Multicenter, Phase II Study of Nab-paclitaxel Combined with Bevacizumab for Unresectable Recurrent or Metastatic Extrapulmonary Neuroendocrine Carcinoma

This is an open-label, phase II study evaluating efficacy and safety of Nab-paclitaxel Combined With Bevacizumab for unresectable Recurrent or metastatic extrapulmonary neuroendocrine carcinoma.

Read the detailed description

Nab-paclitaxel Combined With Bevacizumab will be evaluated in participants who have had ≥ 1 line of previous treatment. The primary endpoint is the Overall Survival (OS).

Being tested
Nab-paclitaxel Combined With Bevacizumab
Medical subject headings
Carcinoma, Neuroendocrine

What participants receive

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

  • Nab-paclitaxel Combined With BevacizumabDrug

    Nab-paclitaxel 150mg/m2 ，iv drip, d1, Bevacizumab 5mg/kg, iv drip, d1, q2w.

Study groups in NCT04705519
Study groupRoleWhat they receive
Nab-paclitaxel Combined With BevacizumabExperimentalNab-paclitaxel, Bevacizumab
Receives: Drug: Nab-paclitaxel Combined With Bevacizumab

What is being measured

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

  1. Overall Survival (OS)

    Duration from the date of initial treatment to the date of death due to any cause

    Measured: an expected average of 24 months

Secondary outcomes (5)

  1. Overall Response Rate (ORR)

    Percentage of patients who achieve partial response (PR) or complete response (CR) based on Response Evaluation Criteria In Solid Tumors (RECIST v1.1).

    Measured: 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 months

  2. Duration of Response (DoR)

    The percentage of patients who achieve complete remission(CR) or partial remission (PR) or stable disease(SD) determined by the RECIST v1.1 criteria.

    Measured: 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 months

  3. Progression Free Survival (PFS)

    A duration from the date of initial treatment to radiographic disease progression or death of any cause

    Measured: an expected average of 24 months

  4. Disease Control Rate (DCR)

    Proportion of objective complete response, partial response and stable patients

    Measured: 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 months

  5. Adverse events

    Including other occasional or rare AEs

    Measured: an expected average of 24 months

Timeline

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

  1. First posted12 Jan 2021
  2. Study start5 Jan 2021
  3. Primary completion30 Sep 2024
  4. Study completion30 Sep 2024

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
79 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04705519
Sponsor's protocol ID
CGOG3006/NEC-BEVAX
Status last verified
Sep 2024
First submitted
6 Jan 2021
Last updated
14 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Zhang P, Li S, Jia R, Hao J, Chen C, Gan S, Li J, Shen L, Lu M. Nab-paclitaxel plus bevacizumab for patients with metastatic extrapulmonary neuroendocrine carcinoma: a phase 2 single-arm study. EClinicalMedicine. 2025 Oct 24;90:103598. doi: 10.1016/j.eclinm.2025.103598. eCollection 2025 Dec.

    PubMed 41209655

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Nab-paclitaxel Combined With Bevacizumab in people with Neuroendocrine Carcinoma, run by Peking University 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 10 inclusion and 17 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: finished, as of the sponsor's last update on 14 Mar 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) (time frame: an expected average of 24 months). 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 NCT04705519, which also lists 1 linked publication.

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 14 Mar 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in