Because most patients with R/M NPC have received long-term maintenance of immunotherapy at the time of initial treatment and the first-line treatment, there are a large number of PD-1 inhibitor refractory patients. How to deal with the ICIs resistance is an urgent problem in clinical practice.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
32
Dalpiciclib, D1-21, po, 150mg, qd, Q4W. Camrelizumab, iv, 200mg, D1, Q3W.
Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGObjective response rate (ORR)
Objective response rate is the rate of patients achieving complete response or partial response for a certain period of time after intervention.
Time frame: 1 year
Median progression-free survival (PFS)
Progression-free survival is defined as the time to the date of death of any cause or the first progress at any site, censored on the last date of tumor evaluation if no progress has happened.
Time frame: 1 year
Median overall survival (OS)
Overall survival is defined as the time to the date of death of any cause, censored on the last date of known survival if no death has happened.
Time frame: 3 years
Duration of response (DoR)
Defined as the time from first documentation of objective response to radiological disease progression
Time frame: 1 year
Disease control rate (DCR)
Disease control rate is the rate of patients achieving complete response, partial response or stable disease
Time frame: 1 year
Incidence of adverse events
NCI-CTCAE 5.0 standard is adopted.
Time frame: 1 year
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