A multicenter randomized controlled study of surgery combined with neoadjuvant and adjuvant therapy for locally advanced recurrent nasopharyngeal carcinoma in comparison to surgery combined with adjuvant therapy
Eligible patients are randomized into the control group and the experimental group. Patients in the experimental group would be administrated 2 courses of neoadjuvant therapy before surgery.After endoscopic surgery, patients would continue to receive 2-4 courses of chemotherapy and 8 courses of immunotherapy. Patients in the control group would firstly receive endoscopic surgery, followed by chemotherapy and immunotherapy. In total, 4 to 6 courses of chemotherapy and 10 courses of immunotherapy would be administrated.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
154
The tumor was resected by endoscopic nasopharyngectomy.
Two courses of Toripalimab Injection and two courses of Toripalimab Injection and Gemcitabine based chemotherapy were given before endoscopic surgery.
Eight courses of Toripalimab Injection and two to four courses of chemotherapy, or until unacceptable side effects.
Eye& ENT Hospital, Fudan University
Shanghai, Shanghai Municipality, China
RECRUITINGFujian Medical University Union Hospital
Fuzhou, China
NOT_YET_RECRUITINGThe People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, China
EFS
Event free survival
Time frame: From randomization and any events(like:progression or toxic effects precluding surgery;inability to resect all gross disease; progression;surgical complications precluding initiation of adjuvant therapy; recurrence;death) up to 1 year
OS
Overall Survival
Time frame: Time interval of randomization and death of any cause, up to 5 years
DFS
Disease free survival
Time frame: From randomization to recurrence, metastasis or death, up to 1 year
LRFS
Local recurrence free survival
Time frame: From randomization to local recurrence or death, up to 1 year
DMFS
Distant metastasis free survival
Time frame: From randomization to distant metastasis or death, up to 1 year
pCR
pathologic complete response
Time frame: Time point of pathological tumor evaluation after sugery, around 2 weeks after sugery
ORR
Objective response rate,Proportion of CR, PR in all patients.
Time frame: Time point of imaging evaluation before treatment(or randomization) and before surgery,up to 1 year
DCR
Disease Control Rate,Proportion of CR, PR and SD in all patients.
Time frame: Time point of imaging evaluation before treatment(or randomization) and before surgery,up to 1 year
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Ten courses of Toripalimab Injection and four to six courses of chemotherapy,or until unacceptable side effects.
Changhai Hospital
Shanghai, China
NOT_YET_RECRUITINGShanghai Sixth People's Hospital
Shanghai, China
NOT_YET_RECRUITINGShanghai Zhongshan Hospital
Shanghai, China
NOT_YET_RECRUITINGShenzhen Second People's Hospital
Shenzhen, China
NOT_YET_RECRUITINGDoR
Duration of response,the time from the first assessment of the tumour as CR or PR to the first assessment of PD or death from any cause (whichever event occurs first).
Time frame: First date of response to the date of progression, up to 5 years
1-and 2-year PFS rate
one- and two-year progression free survival rate
Time frame: one- and two-year
1-and 2-year OS rate
one- and two-year overall survival rate
Time frame: one- and two-year