Phase
Condition
Neuroendocrine Carcinoma
Carcinoma
Treatment
Nab-paclitaxel Combined With Bevacizumab
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 ormetastatic 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 investigatorassessment
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 serumpregnancy test within 7 days prior to receiving the first dose of study medicationand must be willing to use an adequate method of contraception for the course of thestudy through 90 days after the last dose of study medication. Male subjects ofchildbearing potential must agree to use an adequate method of contraceptionstarting with the first dose of study therapy through 90 days after the last dose ofstudy therapy
Exclusion
Exclusion Criteria:
Patients have recovered adverse events associated with pretreatment to Grade 1 orlower with CTCAE v5.0 excluding alopecia
Patients have an active malignancy (except for definitively treated basal cellcarcinoma 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 washoutperiod of oral fluorouracil drugs is 2 weeks), targeted therapy (the washout periodof 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 brainradiotherapy within 4 weeks; brachytherapy (such as implantation of radioactiveparticles) within 60 days; received palliative radiotherapy for bone metastaseswithin 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 (definedas the investigator's judgment cannot be effectively controlled by diuretics orpuncture);
Patients have gastrointestinal diseases such as active gastric and duodenal ulcers,ulcerative colitis, or active bleeding from unresected tumors, or other conditionsjudged that may cause gastrointestinal bleeding or perforation;
Patients with evidence or medical history of thrombosis or obvious bleeding tendencywithin 2 months (bleeding> 30 mL within 2 months, hematemesis, melena, blood in thestool), 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 heartdisease, New York Heart Association (NYHA) congestive heart failure of grade II orabove, severe arrhythmias requiring drug intervention, myocardial infarction withinthe 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 treatmentor have received anti-tuberculosis treatment within 1 year
Is pregnant or breastfeeding
Patients were judged unsuitable as subjects of this trial by investigators.
Study Design
Study Description
Connect with a study center
Beijing Cancer Hospital
Beijing, Beijing 100142
ChinaSite Not Available
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