Back to resultsCamrelizumab Combined With Chemotherapy for Recurrent or Advanced Cervical Neuroendocrine Carcinomas
Primary Purpose
Chemotherapy, Anti-pd-1 Antibody, Cervical Neuroendocrine Carcinoma
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Drug therapy
Sponsored by
About this trial
This is an interventional treatment trial for Chemotherapy
Eligibility Criteria
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
Sites / Locations
- Lei LiRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Study group
Arm Description
Patients will accept therapy consisting of platinum/etoposide/bevacizumab/camrelizumab
Outcomes
Primary Outcome Measures
objective response rate
proportion of partial or complete remission after intervention
Secondary Outcome Measures
severe adverse events
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
these changes include liver/kidney/myocardiac functions, insulin resistance, functions of adrenal gland
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04635956
Brief Title
Camrelizumab Combined With Chemotherapy for Recurrent or Advanced Cervical Neuroendocrine Carcinomas
Official Title
Anti-PD-1 Antibody Camrelizumab Combined With Cisplatin/Paclitaxel/Bevacizumab for Recurrent or Advanced Cervical Neuroendocrine Carcinomas: A Single Arm, Phase II Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 15, 2020 (Actual)
Primary Completion Date
November 15, 2021 (Anticipated)
Study Completion Date
November 15, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Lei Li
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chemotherapy, Anti-pd-1 Antibody, Cervical Neuroendocrine Carcinoma, Adverse Drug Event, Recurrent Cervical Carcinoma, Advanced Cervical Carcinoma, Objective Response Rate
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Intervention of platinum/etoposide/bevacizumab/camrelizumab
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Study group
Arm Type
Experimental
Arm Description
Patients will accept therapy consisting of platinum/etoposide/bevacizumab/camrelizumab
Intervention Type
Drug
Intervention Name(s)
Drug therapy
Intervention Description
6 courses of platinum/etoposide/bevacizumab/camrelizumab and a total period of 12 months bevacizumab/camrelizumab
Primary Outcome Measure Information:
Title
objective response rate
Description
proportion of partial or complete remission after intervention
Time Frame
1 years
Secondary Outcome Measure Information:
Title
severe adverse events
Description
grade 3/4 adverse events and mortality according to criteria of Common Terminology Criteria for Adverse Events (CTCAE) and iRECIST Guideline
Time Frame
1 year
Title
a composite changes of important laboratory testing
Description
these changes include liver/kidney/myocardiac functions, insulin resistance, functions of adrenal gland
Time Frame
1 year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lei Li, M.D.
Phone
+86-139-1198-8831
Email
lilleigh@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ming Wu, M.D.
Phone
+86-138-0122-4549
Email
wuming@pumch.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lei Li, M.D.
Organizational Affiliation
Peking Union Medical College Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lei Li
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lei Li, MD
Phone
8613911988831
Email
lileigh@163.com
12. IPD Sharing Statement
Learn more about this trial
Camrelizumab Combined With Chemotherapy for Recurrent or Advanced Cervical Neuroendocrine Carcinomas
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