About this trial
The trial aimed to compare QL1706 combined with induction chemotherapy plus concurrent chemoradiotherapy (IC+CCRT) versus IC+CCRT alone in High-risk Locoregionally-Advanced Nasopharyngeal Carcinoma (LANPC).
Eligibility criteria
Qualifiers
Age ≥18 and ≤65 years
Patients with histologically confirmed non-keratinizing nasopharyngeal carcinoma according to WHO criteria.
Tumor staged as T4N1 and T1-4N2-3 (AJCC 9th)
Stage II: T1-3N2
Disqualifiers
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).
Positive for hepatitis B surface antigen (HBsAg) with hepatitis B virus DNA >1×103 copies/mL, positive for anti-hepatitis C virus (HCV) antibody , positive for anti-hepatitis C virus (HCV) antibody
Positive for anti-HIV antibody or diagnosed with acquired immunodeficiency syndrome (AIDS).
Trial design
Treatments tested in this trial
- QL1706
- Gemcitabine
- Cisplatin
- Intensity-modulated radiotherapy
Treatment groups
Sponsors and collaborators
Sun Yat-Sen University Cancer Center
Lead sponsor
Sun Yat-sen University
Sponsor institution
Qilu Pharmaceutical Co., Ltd.
Collaborator