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This is a randomized controlled clinical trial of nab-paclitaxel + carboplatin
The enrollment time is expected to be 1.5 year and the observation time is 2 years. The regimen were performed on a 28-day/21-day cycle respectively. Subjects who met the entry criteria were treated in a 2:1 group according to a randomized list: the treatment group was treated with nab-paclitaxel + carboplatin + endostatin regimen, and the control group was treated with paclitaxel + carboplatin. In this trial, the efficacy is evaluated every 8 weeks until disease progression or unacceptable toxicity,or until the investigator deemed that the patient's condition was unacceptable for further treatment. The follow-up period was 24 months after the end of treatment (follow-up patient survival information and new anti-tumor treatment). The planning enrolled sample size for nab-paclitaxel + carboplatin + endostatin group and paclitaxel-carboplatin group were 90 patients and 45 patients, respectively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| nab-paclitaxel + endostatin+ carboplatin | Experimental | nab-paclitaxel + endostatin+ carboplatin nab-paclitaxel 260mg/m2, d1 +Carboplatin AUC=5, d1 +endostatin 15mg, d1-14 q28d |
|
| paclitaxel+carboplatin | Active Comparator | paclitaxel+carboplatin paclitaxel 175 mg/m2, d1+ Carboplatin AUC=5, d1 q21d |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chemotherapeutic Combinations | Drug | nab-paclitaxel 260mg/m2 d1+Carboplatin AUC=5 d1+ endostatin 15mg d1-14,q28d |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival (PFS) | The time from treatment to tumor progression or death | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | response evaluation disease progression defined by Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1) criteria. response (PR), refers to the number of cases with complete and partial response after treatment as a percentage of the total number of evaluable cases | At the end of Cycle 2 (each cycle is 28 days) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lili Mao, Dr. | Contact | 861013261859885 | yunzhongmanbu7848@163.com | |
| Lu Si, Dr. | Contact | 861088196956 |
| Name | Affiliation | Role |
|---|---|---|
| Jun Guo, Dr. | Peking University Cancer Hospital & Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Recruiting | Beijing | Beijing Municipality | 100142 | China |
De-identified individual participant data for all primary and secondary outcome measures will be made available.
Data will be available within 6 months of study completion.
data access requests will be reviewed by an external Independent Review Panel.Requestors will be required to sign a Data Access Agreement.
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| ID | Term |
|---|---|
| D008545 | Melanoma |
| 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 |
|---|---|
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| chemotherapy | Drug | paclitaxel 175 mg/m2 d1+Carboplatin AUC=5 d1, q21d |
|
| Disease Control Rate (DCR) | The disease control rate was the proportion of patients with complete remission, partial remission and stability (SD) in all patients. | At the end of Cycle 2 (each cycle is 28 days) |
| overall survival (OS) | OS was defined as the time from the date of the first administration of trial regimen to the date of death from any cause (event) or last follow-up (censored data). | 3 years |
| Adverse events (AE) | Adverse events (AE) were monitored on an ongoing basis and classified according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0. Patients were assessed for toxicities before each administration, and toxicity was graded accordingly | 3 years |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |