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

  • STATUS
    Recruiting
  • End date
    Jan 5, 2024
  • participants needed
    100
  • sponsor
    Peking University
Updated on 31 January 2021

Summary

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

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).

Details
Condition Neuroendocrine carcinoma
Treatment Nab-paclitaxel Combined With Bevacizumab
Clinical Study IdentifierNCT04705519
SponsorPeking University
Last Modified on31 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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 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) 1.5109/L; Platelets 80109/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

Exclusion Criteria

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
Is pregnant or breastfeeding
Patients were judged unsuitable as subjects of this trial by investigators
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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