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| Name | Class |
|---|---|
| Qilu Pharmaceutical Co., Ltd. | INDUSTRY |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nab-paclitaxel Combined With Bevacizumab | Experimental | Nab-paclitaxel, Bevacizumab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nab-paclitaxel Combined With Bevacizumab | Drug | Nab-paclitaxel 150mg/m2 ,iv drip, d1, Bevacizumab 5mg/kg, iv drip, d1, q2w. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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 |
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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 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
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Beijing | Beijing Municipality | 100142 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41209655 | Derived | 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. |
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| ID | Term |
|---|---|
| D018278 | Carcinoma, Neuroendocrine |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| 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. |
| 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 | an expected average of 24 months |
| Disease Control Rate (DCR) | Proportion of objective complete response, partial response and stable patients | 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 | an expected average of 24 months |
| D009369 | Neoplasms |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |