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Brief Title: Concurrent and Adjuvant PD1 Treatment Combined With Chemo-radiotherapy for High-risk Nasopharyngeal Carcinoma
Official Title: A Multicenter Randomized Clinical Phase 3 Trial of Induction Chemotherapy Plus Concurrent Chemo-radiotherapy With or Without Camrelizumab for High Risk Nasopharyngeal Carcinoma
Study ID: NCT04453826
Brief Summary: Through multicenter, open-label, randomised clinical trials, we intend to demonstrate that concurrent and adjuvant PD-1 treatment added to chemo-radiotherapy could further decrease the rate of disease progression and improve the survival outcome of high risk patients with nasopharyngeal carcinoma compared with those treated with chemo-radiotherapy alone.
Detailed Description: Through multicenter, open-label, randomised clinical trials, high risk patients with nasopharyngeal carcinoma (staged as II-III with SD/PD according to RECIST criteria or EBV DNA of \>0 copies/mL after 3 cycles of GP induction chemotherapy and staged as IVa) are randomized into camrelizumab plus chemo-radiotherapy arm and chemo-radiotherapy arm. The efficacy and safety of patients between these two arms are compared.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China
Cancer Center of Guangzhou Medical University, Guangzhou, Guangdong, China
Yuebei People's Hospital, Shaoguan, Guangdong, China
Zhongshan People's Hospital, Zhongshan, Guangdong, China
The Fifth Affiliated Hospital of Sun Yat-sen University, Zhuhai, Guangdong, China
Wuzhou Red Cross Hospital, Wuzhou, Guangxi, China