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The response rate of traditional first-line chemotherapy for recurrent or persistent advanced cervical cancer was low. This single arm, open, phase II trial would recruit 37 eligible patients. A combination of cisplatin, paclitaxel and apatinib would be given for first 23 patients. If at least 13 patients achieved complete or partial remission, the same regimen would be given for rest patients. The primary end is overall response rate (ORR). The second ends include progression-free survival, overall survival, disease control rate, remission duration, and adverse events. A molecular testing, mainly consisting of genomic analysis, will be carried in the oncologic tissues.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study group | Experimental | The patients would accept the regimen of apatinib combined with cisplatin and paclitaxel |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chemotherapy plus apatinib | Drug | A combination of cisplatin, paclitaxel and apatinib would be given for all patients:
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate | The rates of complete and partial remission | One year |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | The length of time during and after the treatment of the cancer, that a patient lives with the disease but it does not get worse | One year |
| Overall survival | The length of time from either the date of diagnosis or the start of treatment for the cancer, that patients diagnosed with the disease are still alive. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lei Li, M.D. | Peking Union Medical College Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lei Li | Beijing | Beijing Municipality | 100730 | China |
The individual participant data will be available by public reports.
Two year
Public reports
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| C553458 | apatinib |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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A combination of cisplatin, paclitaxel and apatinib would be given for all patients
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|
|
| One year |
| Disease control rate | The rates of complete and partial remission, and stable disease | One year |
| Adverse event rates | The rates of adverse events judged by Common Terminology Criteria for Adverse Events | One years |
| D009369 |
| Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |