Phase III Trial of EBV-DNA-Guided Adaptive Immunotherapy for Advanced Nasopharyngeal Carcinoma
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-65
SponsorSun Yat-sen University
About this trial
This trial evaluated the efficacy of two adjuvant regimens following identical induction and concurrent chemoradiotherapy (IC+CCRT) in locoregionally advanced nasopharyngeal carcinoma (LANPC) patients with persistent EBV DNA positivity or stable disease after three IC cycles. The control arm received adjuvant adebrelimab, while the experimental arm received adebrelimab plus capecitabine.
Eligibility criteria
Qualifiers
Age ≥18 and ≤65 years
Patients with histologically confirmed non-keratinizing nasopharyngeal carcinoma according to WHO criteria.
Eastern Cooperative Oncology Group performance score of 0-1.
Tumor staged as II-III disease (AJCC 9th edition), excluding T3N0-1.
Disqualifiers
Patients with persistent EBV DNA positivity or stable disease following 3 cycles of induction chemotherapy (gemcitabine, cisplatin, and adebrelimab).
Patients must be informed of the investigational nature of this study and give written informed consent, and be willing and able to comply with the study schedule, including follow-up visits, treatment procedures, laboratory testing, and other protocol-related requirements.
Women of childbearing potential (WOCBP) must be willing to adhere to effective contraception during treatment and for 1 year after the last dose of study drug (e.g., condoms, physician-guided regular use of oral contraceptives).
Disease progression after induction chemotherapy
Trial design
Treatments tested in this trial
- Adebrelimab (PD-L1 inhibitor)
- Cisplatin (100mg/m2)
- Intensity-modulated radiotherapy
- Capecitabine
Treatment groups
516 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov