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

NCT04705519 | Completed Phase 2

• 1 other identifier: CGOG3006/NEC-BEVAX
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Neuroendocrine Carcinoma

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS)

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

  an expected average of 24 months

Secondary Outcomes (5)

• Overall Response Rate (ORR)

  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

• Duration of Response (DoR)

  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

• Progression Free Survival (PFS)

  an expected average of 24 months

• Disease Control Rate (DCR)

  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

• Adverse events

  an expected average of 24 months

Study Arms (1)

Nab-paclitaxel Combined With Bevacizumab

EXPERIMENTAL

Nab-paclitaxel, Bevacizumab

Drug: Nab-paclitaxel Combined With Bevacizumab

Interventions

Nab-paclitaxel Combined With Bevacizumab DRUG

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

Nab-paclitaxel Combined With Bevacizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Peking University: lead
• Qilu Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

Related Publications (1)

• 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.

  PMID: 41209655 DERIVED

MeSH Terms

Conditions

Carcinoma, Neuroendocrine

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 6, 2021
• First Posted: January 12, 2021
• Study Start: January 5, 2021
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: March 14, 2025

Record last verified: 2024-09

Locations

CN (1)