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| Name | Class |
|---|---|
| Affiliated Cancer Hospital & Institute of Guangzhou Medical University | OTHER |
| Zhongshan People's Hospital, Guangdong, China | OTHER |
| Yuebei People's Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Camrelizumab plus chemo-radiotherapy arm | Experimental | 3 cycles of gemcitabin and cisplatin induction chemotherapy plus concurrent chemo-radiotherapy with concurrent and adjuvant camrelizumab therapy. |
|
| Chemo-radiotherapy arm | Active Comparator | 3 cycles of gemcitabin and cisplatin induction chemotherapy plus concurrent chemo-radiotherapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Camrelizumab plus chemo-radiotherapy | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progress-free survival (PFS) | Defined as time from randomization to locoregional or distant metastasis relapse or death from any cause, whichever occurred first. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | Defined as the time interval from randomization to death due to any cause. | 3 years |
| Distant Metastasis-Free Survival (DMFS) | Defined as the time interval from randomisation to the date of first distant metastases. |
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Inclusion Criteria:
Histologically confirmed non-keratinizing nasopharyngeal carcinoma (differentiated or undifferentiated type, i.e., WHO type II or type III).
Staged as T4N0-2M0,T1-4N3M0 (stage IVa) at diagnosis (according to the 8th AJCC edition).
Staged as T1-3N1-2M0, T2-3N0M0 (stage II-III) with SD/PD according to RECIST criteria or EBV DNA of >0 copies/mL after 3 cycles of GP induction chemotherapy.
Aged between 18-70 years.
Karnofsky scale (KPS)≥70.
Normal bone marrow function.
Normal liver and kidney function:
Given written informed consent.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ming-Yuan Chen, MD, PhD | Contact | : 86-20-87343624 | chmingy@mail.sysu.edu.cn | |
| Rui You, MD, PhD | Contact | 86-13580439820 | yourui@sysucc.org.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Center | Recruiting | Guangzhou | Guangdong | 510060 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41667193 | Derived | You R, Xu GQ, Ding X, Liang JH, Liu ZG, Zou X, Liu YP, Hu GY, Liu YM, Duan CY, Liu LZ, Zhang WJ, Liu Q, Li HF, Ouyang YF, Duan XT, Wang Q, Peng L, Liang JL, Feng ZK, Qin ZH, Liu X, He ZK, Zhang B, Long GX, Jiang YH, Lei F, Huang PY, Hua YJ, Chen MY. Standard chemoradiotherapy with concurrent and adjuvant camrelizumab in patients with high risk nasopharyngeal carcinoma: multicentre, randomised, open label, phase 3 trial. BMJ. 2026 Feb 10;392:e085863. doi: 10.1136/bmj-2025-085863. |
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| Wuzhou Red Cross Hospital |
| OTHER |
| Fifth Affiliated Hospital, Sun Yat-Sen University | OTHER |
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|
| Chemo-radiotherapy alone | Drug |
|
|
| 3 years |
| Locoregional Relapse-Free Survival (LRRFS) | Defined as the time from randomisation to the date of first locoregional relapse. | 3 years |
| Incidence of treatment related acute complications | The proportion of patients with treatment related acute complications according to NCI-CTC5.0 criteria and RTOG criteria. | up to 1 years |
| Incidence of treatment related late complications | The proportion of patients with treatment related late complications according to NCI-CTC5.0 criteria and RTOG criteria. | up to 3 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. | up to 3 years |
| Score 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. | up to 3 years |
| Cancer Center of Guangzhou Medical University | Not yet recruiting | Guangzhou | Guangdong | 510095 | China |
|
| Yuebei People's Hospital | Not yet recruiting | Shaoguan | Guangdong | 512025 | China |
|
| Zhongshan People's Hospital | Recruiting | Zhongshan | Guangdong | 528403 | China |
|
| The Fifth Affiliated Hospital of Sun Yat-sen University | Recruiting | Zhuhai | Guangdong | 519000 | China |
|
| Wuzhou Red Cross Hospital | Not yet recruiting | Wuzhou | Guangxi | 543002 | China |
|
| ID | Term |
|---|---|
| D009303 | Nasopharyngeal Neoplasms |
| ID | Term |
|---|---|
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009302 | Nasopharyngeal Diseases |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| C000631724 | camrelizumab |
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