Condition or disease | Intervention/treatment | Phase |
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Nasopharyngeal Carcinoma | Drug: SHR-1210 | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 155 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Single-arm, Open Label, Multi-center, Phase 2 Study of SHR-1210 in Recurrent/Metastatic Nasopharyngeal Carcinoma Patients Who Have Received Previous At Least Two Lines of Chemotherapy. |
Actual Study Start Date : | August 14, 2018 |
Estimated Primary Completion Date : | June 30, 2020 |
Estimated Study Completion Date : | December 30, 2020 |
Arm | Intervention/treatment |
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Experimental: Injection SHR-1210
SHR-1210 injection, 200 mg/dose, intravenous infusion over 30 minutes.
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Drug: SHR-1210
A humanized monoclonal immunoglobulin PD-1 antibody
Other Name: Camrelizumab
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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Adequate laboratory parameters during the screening period as evidenced by the following:
Exclusion Criteria:
Received a systematic antibiotics within 4 weeks of the first dose of study medication.
Pregnancy or breast feeding.
China, Guangdong | |
Cancer Center of Sun-Yat Sen University (CCSYSU) | |
Guangzhou, Guangdong, China, 510060 |
Principal Investigator: | Li Zhang, MD | Cancer Center of Sun-Yat Sen University (CCSYSU) | |
Study Director: | Qing Yang, MD | Jiangsu HengRui Medicine Co., Ltd. |
Tracking Information | |||||||
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First Submitted Date ICMJE | May 30, 2018 | ||||||
First Posted Date ICMJE | June 15, 2018 | ||||||
Last Update Posted Date | June 23, 2020 | ||||||
Actual Study Start Date ICMJE | August 14, 2018 | ||||||
Estimated Primary Completion Date | June 30, 2020 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
Objective Response Rate (ORR) assess by Independent Review Committee (IRC) [ Time Frame: from first patient first visit to 6 month after last patient first visit ] Based on Response Evaluation Criteria in Solid Tumors 1.1 (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 | SHR-1210 in Recurrent/Metastatic Nasopharyngeal Carcinoma Who Have Received Previous At Least Two Lines of Chemotherapy. | ||||||
Official Title ICMJE | A Single-arm, Open Label, Multi-center, Phase 2 Study of SHR-1210 in Recurrent/Metastatic Nasopharyngeal Carcinoma Patients Who Have Received Previous At Least Two Lines of Chemotherapy. | ||||||
Brief Summary | This is an open label, single-arm, multi-center, phase 2 Study of SHR-1210 in recurrent/metastatic nasopharyngeal carcinoma(R/M NPC) patients who have received previous at least two lines of chemotherapy. | ||||||
Detailed Description | The primary objective of this phase 2 study is to assess objective response rate of SHR-1210 in patients with R/M NPC. The secondary objective is to observe the duration of response, progression free survival, time to response, overall survival and safety of SHR-1210 in R/M NPC. ADA is also investigated. | ||||||
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 | Nasopharyngeal Carcinoma | ||||||
Intervention ICMJE | Drug: SHR-1210
A humanized monoclonal immunoglobulin PD-1 antibody
Other Name: Camrelizumab
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Study Arms ICMJE | Experimental: Injection SHR-1210
SHR-1210 injection, 200 mg/dose, intravenous infusion over 30 minutes.
Intervention: Drug: SHR-1210
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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 | ||||||
Estimated Enrollment ICMJE |
155 | ||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||
Estimated Study Completion Date ICMJE | December 30, 2020 | ||||||
Estimated Primary Completion Date | June 30, 2020 (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 75 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 | NCT03558191 | ||||||
Other Study ID Numbers ICMJE | SHR-1210-II-209 | ||||||
Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Jiangsu HengRui Medicine Co., Ltd. | ||||||
Study Sponsor ICMJE | Jiangsu HengRui Medicine Co., Ltd. | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | Jiangsu HengRui Medicine Co., Ltd. | ||||||
Verification Date | June 2020 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |