This study is to investigate the efficacy and safety of the induction chemotherapy + concurrent chemoradiotherapy（CCRT）combined with toripalimab and endostar treatment, in comparison with the induction chemotherapy + concurrent chemoradiotherapy（CCRT）, in treating locally advanced high-risk nasopharyngeal carcinoma
With ECOG score 0-1.
Subjective aged 18-65 years, male or non-pregnant female.
Pathologically diagnosed as nasopharyngeal non-keratinizing carcinoma (differentiated or undifferentiated, i.e., the WHO type II or III).
Stage IVa (8th AJCC/UICC stage) T4 and/or N3, untreated patients with nasopharyngeal carcinoma.
Patients with nasopharyngeal carcinoma with recurrence and distant metastasis.
Pathologically diagnosed as keratinizing squamous cell carcinoma (WHO classification type I).
Patients who had undergone radiotherapy or systemic chemotherapy.
Pregnant or breastfeeding females, or females in fertility period while with no effective contraceptive measures.
Parallel
Toripalimab, Endostar Combined With Radiotherapy and Chemotherapy
DrugToripalimab: 240 mg, Q3W, starting on D1, for totally 12 cycles Endostar: 7.5 mg/m2/d, continuous intravenous pumping for 10 days, Q3W, starting on D1, for totally 5 cycles
IC＋CCRT
DrugIC＋CCRT
progression-free survival, PFS
calculated from the date of randomisation to the date of the documented local or regional relapse, distant metastasis, or death from any cause, whichever occurred first. distant failure, or death from any cause, whichever occurred first.
Overall Survival，OS
the time from random assignment to death from any cause or censored at the date of last follow-up.
locoregional relapse-free Survival, LRFS
the time from random assignment to local or regional relapse.
Distant metastasis-free survival,DMFS
calculated from date of randomisation to the first distant failure
Overall response rate (ORR)
complete response (CR) + partial response (PR)
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First Affiliated Hospital of Guangxi Medical University
Lead sponsor
Shandong Cancer Hospital and Institute
Collaborator
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Collaborator
The Affiliated Hospital Of Guizhou Medical University
Collaborator
Xiangya Hospital of Central South University
Collaborator
Jiangxi Provincial Cancer Hospital
Collaborator
Zhejiang Cancer Hospital
Collaborator
Fourth Affiliated Hospital of Guangxi Medical University
Collaborator
LiuZhou People's Hospital
Collaborator
Guilin Medical College
Collaborator
Affiliated Hospital of North Sichuan Medical College
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
