Concurrent and Adjuvant PD1 Treatment Combined With Chemo-radiotherapy for High-risk Nasopharyngeal Carcinoma
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-70
SponsorSun Yat-sen University
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
Histologically confirmed keratinized squamous cell carcinoma (WHO type I) or basal squamous cell carcinoma.
Recurrent or metastatic nasopharyngeal carcinoma.
Staged as II-III which is evaluated as PR or CR and EBV DNA of 0 copies/mL after 3 cycles of GP induction chemotherapy.
Has known allergy to large molecule protein products or any compound of study therapy.
Trial design
Treatments tested in this trial
- Camrelizumab plus chemo-radiotherapy
- Chemo-radiotherapy alone
Treatment groups
388 Participants
are divided into 2 treatment groupsSponsors and collaborators
Sun Yat-sen University
Lead sponsor
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Collaborator
Zhongshan People's Hospital, Guangdong, China
Collaborator
Yuebei People's Hospital
Collaborator
Wuzhou Red Cross Hospital
Collaborator
Fifth Affiliated Hospital, Sun Yat-Sen University
Collaborator
Source ClinicalTrials.gov