Through multicenter, open-label, randomised clinical trials, we intend to demonstrate that PD-1 treatment added to salvage surgery could further decrease the rate of disease progression and improve the survival outcome of patients with resectable locally recurrent nasopharyngeal carcinoma compared with those treated with salvage surgery alone.
Through multicenter, open-label, randomised clinical trials, patients with resectable locally recurrent nasopharyngeal carcinoma are randomized into salvage surgery plus PD-1 treatment group and salvage surgery alone group. The efficacy and safety of patients between these two groups are compared.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
218
Toripalimab: 240 mg, intravenous injection over 60 minutes (Q3W); Toripalimab should be completed for 2 cycles at 1-2 weeks before surgery, and continually applied since 1-2 weeks after surgery until confirmed disease progression, death, unacceptable toxicity, withdrawal of consent, investigator decision, or 1 year.
Endoscopic nasopharyngectomy is used for recurrent nasopharyngeal tumor and selective neck dissection for recurrent regional lymph node.
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGThe First Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, China
NOT_YET_RECRUITINGNanfang Hospital of Southern Medical University
Guangzhou, Guangdong, China
Disease-free survival
Defined as the time interval from randomization to disease progression or death due to any cause, whichever come first.
Time frame: 2 years
Objective Response Rate
Defined as the proportion of patients with radiologically confirmed complete or partial response according to RECIST 1.1.
Time frame: 3-5 weeks
Major Pathological Response Rate
Defined as the proportion of patients with no more than 10% viable tumor cells which is identified on routine hematoxylin and eosin staining within the recurrent nasopharyngeal tumor and/or regional lymph node after neoadjuvant PD-1 treatment.
Time frame: 4-6 weeks
Overall Survival
Defined as the time interval from randomization to death due to any cause.
Time frame: 2 years
Distant Metastasis-Free Survival
Defined as the time interval from randomisation to the date of first distant metastases.
Time frame: 2 years
Locoregional Relapse-Free Survival
Defined as the time from randomisation to the date of first locoregional relapse.
Time frame: 2 years
Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0)
Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0) before treatment, during treatment, after treatment.
Time frame: up to 2 years
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The Fifth Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
NOT_YET_RECRUITINGThe First People's Hospital of Foshan
Guangzhou, Guangdong, China
NOT_YET_RECRUITINGZhongshan People's Hospital
Zhongshan, Guangdong, China
NOT_YET_RECRUITINGThe Tenth Affiliated Hospital, Sun Yat-Sen University
Nanchang, Jiangxi, China
NOT_YET_RECRUITINGScore of survival quality according to the EORTC Quality of Life Questionnaire Head and Neck (The QLQ-H&N35)
Score of survival quality according to the EORTC Quality of Life Questionnaire Head and Neck (The QLQ-H\&N35) before treatment, during treatment, after treatment.
Time frame: up to 2 years