Advanced Cervical Carcinoma, Adverse Drug Event, Anti-pd-1 Antibody, Cervical Neuroendocrine Carcinoma, Chemotherapy, Objective Response Rate, Recurrent Cervical Carcinoma
Conditions
Brief summary
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.
Interventions
DRUGDrug therapy
6 courses of platinum/etoposide/bevacizumab/camrelizumab and a total period of 12 months bevacizumab/camrelizumab
Sponsors
Lei Li
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Intervention of platinum/etoposide/bevacizumab/camrelizumab
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Confirmed recurrent or advanced cervical neuroendocrine carcinoma * Aged 18 years or older * No immunosuppressive disease * Signed an approved informed consents * Performance status of ECOG 0-1
Exclusion criteria
* Not meeting all of the inclusion criteria
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| objective response rate | 1 years | proportion of partial or complete remission after intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| severe adverse events | 1 year | grade 3/4 adverse events and mortality according to criteria of Common Terminology Criteria for Adverse Events (CTCAE) and iRECIST Guideline |
| a composite changes of important laboratory testing | 1 year | these changes include liver/kidney/myocardiac functions, insulin resistance, functions of adrenal gland |
Countries
China
Contacts
Primary ContactLei Li, M.D.
Backup ContactMing Wu, M.D.
Outcome results
None listed