The aim of the study was to determine the efficacy and safety of toripalimab combined with radiotherapy in the treatment of oligometastatic nasopharyngeal carcinoma
Chemotherapy has been widely used for the treatment of relapsed or metastatic nasopharyngeal carcinoma. However, the long-term survival and quality of life of patients was still unsatisfactory. In this prospective, multicenter, single arm study, the efficacy and safety of toripalimab combined with radiotherapy in the treatment of oligometastatic nasopharyngeal carcinoma is determined.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Toripalimab: 240mg, iv. Q3W for 1 year or until disease progression/intolerable toxicity Radiotherapy: Newly diagnosed patients: IMRT for nasopharynx lesions and cervical lymph nodes, pGTVnx 70 Gy, pGTVnd 99Gy, pCTV1, 60 Gy, pCTV2, 54 Gy, 33 times, completed in 7 weeks. Relapsed patients: IMRT for nasopharynx lesions and cervical lymph nodes, pGTVnx 60Gy, pGTVnd 60Gy, 20-25 times, completed in 4-5 weeks. Newly diagnosed and relapsed patients: SBRT for oligometastatic lesions, pGTV 25-40 Gy, 3-5 times, completed in 1-2 weeks.
Xinqiao Hospital of Chongqing
Chongqing, Chongqing Municipality, China
RECRUITINGthe second affiliated hospital of Army medical university
Chongqing, Chongqing Municipality, China
RECRUITING1-year progression-free survival rate according to RECIST v1.1
To evaluate the efficacy of Toripalimab plus radiotherapy in patients with oligometastatic nasopharyngeal carcinoma, as measured by 1-year progression-free survival rate according to RECIST v1.1
Time frame: From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. 1 year
PFS according to RECIST v1.1
To evaluate the efficacy of Toripalimab plus radiotherapy in patients with oligometastatic nasopharyngeal carcinoma, as measured by progression-free survival rate according to RECIST v1.1
Time frame: From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to 2 approximately years
OS
To evaluate the efficacy of Toripalimab plus radiotherapy in patients with oligometastatic nasopharyngeal carcinoma, as measured by overall survival (OS)
Time frame: up to 5 years
2-year progression-free survival rate according to RECIST v1.1
To evaluate the PFS rate at 2 years in the treatment arm
Time frame: From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to 2 approximately years
2-year overall survival
To evaluate the OS rate at 2 years in the treatment arm
Time frame: From date of randomization until death, loss to follow-up, or study termination by the Sponsor whichever occurs first.Up to 3.5 approximately years
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1-year progression-free survival rate according to irRECIST
To evaluate the efficacy of Toripalimab plus radiotherapy in patients with oligometastatic nasopharyngeal carcinoma, as measured by 1-year progression-free survival rate according to irRECIST
Time frame: From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to 1 approximately year
ORR according to RECIST v1.1
To evaluate the efficacy of Toripalimab plus radiotherapy in patients with oligometastatic nasopharyngeal carcinoma, as measured by investigator-assessed overall response rate (ORR) according to RECIST v1.1.
Time frame: From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to 2 approximately years
DCR according to RECIST v1.1
To evaluate the efficacy of Toripalimab plus radiotherapy in patients with oligometastatic nasopharyngeal carcinoma, as measured by investigator-assessed disease control rate (DCR) according to RECIST v1.1
Time frame: From date of consent informed until 60 days after the last investigational product administration. Up to 2 approximately years
DoR according to RECIST v1.1
To evaluate the efficacy of Toripalimab plus radiotherapy in patients with oligometastatic nasopharyngeal carcinoma, as measured by investigator-assessed duration of response (DoR) according to RECIST v1.1
Time frame: From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to 2 approximately years
AE(SAE)
Incidence of serious adverse events(SAE) as assessed by CTCAE version 5.0
Time frame: From date of consent informed until 60 days after the last investigational product administration. Up to 2 approximately years