This is an open-label, single center, non-randomized, phase I trial to evaluate the safety and efficacy of gemcitabine combined with apatinib and toripalimab in patients with the recurrent or metastatic nasopharyngeal carcinoma.
This is an open-label, single center, non-randomized, phase I trial to evaluate the safety and efficacy of gemcitabine combined with apatinib and toripalimab in patients with the recurrent or metastatic nasopharyngeal carcinoma. 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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
41
Gemcitabine injection, gemcitabine 1000mg/m2, Day 1 and Day 8 of each 21 day, maximum 6 cycles. Apatinib for oral administration, 250mg, once a day. Apatinib maintenance. Toripalimab injection, 240mg, Day 1 each 21day. Toripalimab maintenance.
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Adverse events
The safety 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.
Time frame: 12months
The proportion of patients who achieved an objective response
Defined as those with radiologically confirmed complete or partial response according to RECIST 1.1 assessed by the investigator;
Time frame: 12 months
The proportion of patients who achieved disease control,
Defined as those with RECIST-defined objective response or stable disease;
Time frame: 12months
The proportion of patients who achieved clinical benefit
Defined as those with confirmed objective response or stable disease that lasted for at least 6 months;
Time frame: 12 months
Progression-free survival (median and at 6 and 12 months)
Defined from the enrolment to RECISTdefined progression or death from any causes;
Time frame: 12 months
Duration of response
Defined as the time from first documentation of objective response to radiological disease progression.
Time frame: 12 months
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