A Study to Evaluate the Safety and Efficacy of Using the Combination Treatment of SHR-1210, Gemcitabine and Cis-platinum by Recurrent and Metastatic NPC Subjects
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03121716|
Recruitment Status : Recruiting
First Posted : April 20, 2017
Last Update Posted : June 15, 2017
|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 :||February 2018|
|Estimated Study Completion Date :||April 2018|
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.Drug: Gemcitabine
Other Name: Gemcitabine Hydrochloride for InjectionDrug: cis-platinum
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
|Contact: Qing Yangemail@example.com|
|Contact: Qing Yang +8615705155017 firstname.lastname@example.org|