This is a study to evaluate the efficacy and safety of TQB2450 injection combination with Intensity-modulated Radiotherapy in patients with inoperable locally recurrent nasopharyngeal carcinoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
TQB2450 is a humanized monoclonal antibody targeting programmed death ligand-1 (PD-L1), which prevents PD-L1 from binding to PD-1 and B7.1 receptors on T cell surface, restores T cell activity, thus enhancing immune response and has potential to treat various types of tumors.
Intensity-modulated conformal radiotherapy (IMRT) is a kind of three dimensional conformal radiotherapy, which requires the dose intensity in the radiation field to be adjusted according to certain requirements.
Sun Yat-sen University Cancer Hospital
Guangzhou, Guangdong, China
Overall response rate (ORR)
Percentage of participants achieving complete response (CR) and partial response (PR).
Time frame: up to 48 weeks
Disease control rate(DCR)
Percentage of participants achieving complete response (CR) and partial response (PR) and stable disease (SD).
Time frame: up to 48 weeks
Duration of Response (DOR)
The time when the participants first achieved complete or partial remission to disease progression.
Time frame: up to 48 weeks
Progression-free survival (PFS)
PFS defined as the time from first dose until the first documented progressive disease (PD) or death from any cause.
Time frame: up to 48 weeks
12-month progression-free survival rate
12-month PFS defined as the time from first administration until the first documented progressive disease (PD) or death from any cause within 12 months.
Time frame: up to 48 weeks
12-month survival rate
12-month survival rate defined as the time from first administration to death from any cause within 12 months.
Time frame: up to 48 weeks
24-month survival rate
24-month survival rate defined as the time from first administration to death from any cause within 24 months.
Time frame: up to 96 weeks
Local regional recurrence-free survival (LRRFs)
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The time interval between the patient's first medication and the appearance of local imaging progress.
Time frame: up to 48 weeks
Distant metastasis-free survival (DMFS)
The time interval between the patient's first medication and the appearance of distant metastasis imaging progression or death.
Time frame: up to 48 weeks
Overall survival (OS)
OS defined as the time from randomization to death from any cause. Participants who do not die at the end of the extended follow-up period, or were lost to follow-up during the study, were censored at the last date they were known to be alive.
Time frame: up to 96 weeks