Camrelizumab Combined With Chemotherapy for Recurrent or Advanced Cervical Neuroendocrine Carcinomas
Anti-PD-1 Antibody Camrelizumab Combined With Cisplatin/Paclitaxel/Bevacizumab for Recurrent or Advanced Cervical Neuroendocrine Carcinomas: A Single Arm, Phase II Trial
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Nov 2020
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 15, 2020
CompletedStudy Start
First participant enrolled
November 15, 2020
CompletedFirst Posted
Study publicly available on registry
November 19, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 15, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 15, 2021
CompletedNovember 19, 2020
November 1, 2020
1 year
November 15, 2020
November 15, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
objective response rate
proportion of partial or complete remission after intervention
1 years
Secondary Outcomes (2)
severe adverse events
1 year
a composite changes of important laboratory testing
1 year
Study Arms (1)
Study group
EXPERIMENTALPatients will accept therapy consisting of platinum/etoposide/bevacizumab/camrelizumab
Interventions
6 courses of platinum/etoposide/bevacizumab/camrelizumab and a total period of 12 months bevacizumab/camrelizumab
Eligibility Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Lei Lilead
Study Sites (1)
Lei Li
Beijing, Beijing Municipality, 100730, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lei Li, M.D.
Peking Union Medical College Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
November 15, 2020
First Posted
November 19, 2020
Study Start
November 15, 2020
Primary Completion
November 15, 2021
Study Completion
November 15, 2021
Last Updated
November 19, 2020
Record last verified: 2020-11