Apatinib and Camrelizumab in Recurrent or Metastatic Nasopharyngeal Carcinoma With First-line Treatment Failure
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ClinicalTrials.gov Identifier: NCT04586088 |
Recruitment Status :
Active, not recruiting
First Posted : October 14, 2020
Last Update Posted : May 6, 2023
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Sponsor:
Sun Yat-sen University
Information provided by (Responsible Party):
Ming-Yuan Chen, Sun Yat-sen University
Tracking Information | |||||
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First Submitted Date ICMJE | October 7, 2020 | ||||
First Posted Date ICMJE | October 14, 2020 | ||||
Last Update Posted Date | May 6, 2023 | ||||
Actual Study Start Date ICMJE | May 5, 2020 | ||||
Actual Primary Completion Date | June 2, 2022 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Objective response rate [ Time Frame: 1 year ] Defined as the proportion of patients whose tumors shrink to complete response (CR) or partial response (PR) and remain for a certain period of time according to RECIST 1.1
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Apatinib and Camrelizumab in Recurrent or Metastatic Nasopharyngeal Carcinoma With First-line Treatment Failure | ||||
Official Title ICMJE | Apatinib Combined With Camrelizumab in Recurrent or Metastatic Nasopharyngeal Carcinoma Who Failed at Least the First-line Treatment | ||||
Brief Summary | This is a prospective phase II clinical trial to evaluate the efficacy and safety of apatinib and camrelizumab in recurrent or metastatic nasopharyngeal carcinoma who failed at least the first-line treatment. | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 2 | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | Drug: Apatinib plus Camrelizumab
Subjects receive Apatinib, 250mg, QD and Camrelizumab, 200mg, D1, Q3W. Treatment was continued until confirmed disease progression, death, unacceptable toxicity, withdrawal of consent, or investigator decision.
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Study Arms ICMJE | Experimental: Apatinib plus Camrelizumab arm
Subjects receive apatinib plus camrelizumab
Intervention: Drug: Apatinib plus Camrelizumab
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Active, not recruiting | ||||
Actual Enrollment ICMJE |
58 | ||||
Original Estimated Enrollment ICMJE |
57 | ||||
Estimated Study Completion Date ICMJE | September 5, 2023 | ||||
Actual Primary Completion Date | June 2, 2022 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 70 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | China | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT04586088 | ||||
Other Study ID Numbers ICMJE | SYSUCC-CMY-2020-2103 | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Current Responsible Party | Ming-Yuan Chen, Sun Yat-sen University | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | Sun Yat-sen University | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | Sun Yat-sen University | ||||
Verification Date | May 2023 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |