The aim of this study is to compare the efficacy of Toripalimab Combined with GP Regimen Chemotherapy Versus GP Regimen Chemotherapy for Primary Metastatic NPC.
About 4-10% of patients with nasopharyngeal carcinoma (NPC) have metastatic disease at diagnosis. The treatment recommendation of primary metastatic NPC is systemic chemotherapy. However, the optimal regimen is yet to determine due to lack of prospective randomized trial for this unique group of patients. Generally, GP regimen is used as the first-line treatment of primary metastatic NPC. The aim of this study is to compare the efficacy of Toripalimab Combined with GP Regimen Chemotherapy Versus GP Regimen Chemotherapy for Primary Metastatic NPC.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
PD-1 inhibitor
IMRT to the nasopharynx and neck
Systemic chemotherapy
Xiaomin Ou
Shanghai, China
Progression-free survival
PFS, defined as the time from randomization to the first documented objective tumor progression or death from any cause
Time frame: 5 year
Objective Response Rate of Systemic chemotherapy
ORR according to RECIST 1.1 Criteria
Time frame: At the end of Cycle 6 of chemotherapy (each cycle is 21 days)
Disease Control Rate of Systemic chemotherapy
DCR according to RECIST 1.1 Criteria
Time frame: At the end of Cycle 6 of chemotherapy (each cycle is 21days)
The proportion of patients received radiotherapy to nasopharynx
Only patients with disease control after systemic chemotherapy will receive radiotherapy
Time frame: 2 year
Overall Survival
Defined from date of randomization to date of first documentation of death from Defined from date of randomization to date of first documentation of death from any cause or censored at the date of the last follow-up.
Time frame: 5 year
Progression-free Survival Rate
Defined from date of randomization to date of first documentation of progression or death due to any cause.
Time frame: 1 year, 2 year rates
Overall Survival Rate
Defined from date of randomization to date of first documentation of death from Defined from date of randomization to date of first documentation of death from any cause or censored at the date of the last follow-up.
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Adjuvant chemotherapy after radiation
Time frame: 1 year, 2 year rates
the Incidence of Adverse Effect
According to CTCAE 4.0.03
Time frame: 1 year
Changes of Quality of life, according to EORTC QLQ-C30
According to EORTC QLQ-C30
Time frame: 1 year
Changes of Quality of life, according to EORTC QLQ-H&N35
According to EORTC QLQ-H\&N35
Time frame: 1 year