Nab-paclitaxel Combined with Bevacizumab in the Treatment of Metastatic Extrapulmonary Neuroendoc… (NCT04705519) | Clinical Trial Compass
CompletedPhase 2
Nab-paclitaxel Combined with Bevacizumab in the Treatment of Metastatic Extrapulmonary Neuroendocrine Carcinoma
China79 participantsStarted 2021-01-05
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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:
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);