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Recurrent or advanced cervical neuroendocrine carcinoma (NEC) is refractory to multimodal treatment, even to extensive therapy. Chemotherapy, consisting of platinum and etoposide, remains the main therapy for recurrent or advanced cervical NEC. In addition, bevacizumab has shown progression-free benefits in recurrent or advanced cervical cancer. Case report suggested anti-PD-1 antibody may have antitumor activities in NEC. Based on these evidences, a phase 2, single arm trial is conducted to explore the objective response rate (ORR) of platinum/etoposide/bevacizumab/anti-PD-1 antibody (camrelizumab) for the treatment of recurrent or advanced cervical NEC. This trial is to enroll 20 patients, who would accept 6 courses of platinum/etoposide/bevacizumab/camrelizumab. If the patient achieved complete or partial remission, a total period of 12 months bevacizumab/camrelizumab will be given as maintain therapy. The primary endpoint is ORR. The second endpoints are severe adverse events according to criteria of Common Terminology Criteria for Adverse Events (CTCAE) and iRECIST Guideline, and critical changes of laboratory testing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study group | Experimental | Patients will accept therapy consisting of platinum/etoposide/bevacizumab/camrelizumab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Drug therapy | Drug | 6 courses of platinum/etoposide/bevacizumab/camrelizumab and a total period of 12 months bevacizumab/camrelizumab |
|
| Measure | Description | Time Frame |
|---|---|---|
| objective response rate | proportion of partial or complete remission after intervention | 1 years |
| Measure | Description | Time Frame |
|---|---|---|
| severe adverse events | grade 3/4 adverse events and mortality according to criteria of Common Terminology Criteria for Adverse Events (CTCAE) and iRECIST Guideline | 1 year |
| a composite changes of important laboratory testing |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lei Li, M.D. | Contact | +86-139-1198-8831 | lilleigh@163.com | |
| Ming Wu, M.D. | Contact | +86-138-0122-4549 | wuming@pumch.cn |
| Name | Affiliation | Role |
|---|---|---|
| Lei Li, M.D. | Peking Union Medical College Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lei Li | Recruiting | Beijing | Beijing Municipality | 100730 | China |
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Intervention of platinum/etoposide/bevacizumab/camrelizumab
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these changes include liver/kidney/myocardiac functions, insulin resistance, functions of adrenal gland
| 1 year |
| ID | Term |
|---|---|
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| 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 |
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| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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