A Study to Evaluate the Safety and Efficacy of SHR-1210, Gemcitabine and Cis-platinum by R/M NPC Subjects
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|ClinicalTrials.gov Identifier: NCT03121716|
Recruitment Status : Unknown
Verified December 2018 by Jiangsu HengRui Medicine Co., Ltd..
Recruitment status was: Active, not recruiting
First Posted : April 20, 2017
Last Update Posted : December 19, 2018
|Condition or disease||Intervention/treatment||Phase|
|Nasopharyngeal Carcinoma||Biological: SHR-1210 Drug: Gemcitabine Drug: cis-platinum||Phase 1|
This is an open-label, single center, nonrandomized, Phase 1 study to evaluate safety and efficacy of using the combination treatment of SHR-1210, gemcitabine and cis-platinum by recurrent and metastatic NPC.
The safety of SHR-1210 will be assessed by ongoing reviews of clinical laboratory tests, Eastern Cooperative Oncology Group (ECOG) performance status, physical examination, electrocardiogram (ECG), and adverse events. Evaluations of immune safety will also be conducted (immune-related adverse events (AEs), or labs of autoimmune sera, inflammatory events, and immunogenicity). Safety evaluations (both clinical and laboratory) are performed at baseline, before each study treatment, and throughout the study.Tumor response will be assessed by radiographic examination in screening visit and every 2 cycles after first dose.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label, Single Center, Nonrandomized, Phase 1 Study to Evaluate Safety and Efficacy of Using the Combination Treatment of SHR-1210, Gemcitabine and Cis-platinum by Recurrent and Metastatic NPC|
|Actual Study Start Date :||April 26, 2017|
|Estimated Primary Completion Date :||April 2019|
|Estimated Study Completion Date :||August 2019|
Experimental: SHR-1210, gemcitabine and cis-platinum
Subjects receive SHR-1210 200mg (Day 1) and gemcitabine 1000mg/m2 (Day 1 and Day 8)and cis-platinum 80mg/m2 (Day 1) of each 21-day cycle for at most 6 cycles, followed by SHR-1210 200mg every three weeks (Q3W) maintenance for the remainder of the study or until documented PD.
SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody.
Other Name: Gemcitabine Hydrochloride for Injection
Other Name: Cisplantin Injection
- progression of disease [ Time Frame: 28 days ]progression of disease by radiographic examination
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03121716
|Study Director:||Qing Yang, MD||Jiangsu HengRui Medicine Co., Ltd.|