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.
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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
79
Nab-paclitaxel 150mg/m2 ,iv drip, d1, Bevacizumab 5mg/kg, iv drip, d1, q2w.
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Overall Survival (OS)
Duration from the date of initial treatment to the date of death due to any cause
Time frame: an expected average of 24 months
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).
Time frame: 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)
The percentage of patients who achieve complete remission(CR) or partial remission (PR) or stable disease(SD) determined by the RECIST v1.1 criteria.
Time frame: 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)
A duration from the date of initial treatment to radiographic disease progression or death of any cause
Time frame: an expected average of 24 months
Disease Control Rate (DCR)
Proportion of objective complete response, partial response and stable patients
Time frame: 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
Including other occasional or rare AEs
Time frame: an expected average of 24 months
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