QL1706 (PD-1/CTLA-4 Bi-specific Antibody) and Chemoradiotherapy in Locoregionally-advanced Nasopharyngeal Carcinoma.

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-65
SponsorSun Yat-Sen University Cancer Center

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

580 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Sun Yat-Sen University Cancer Center

Lead sponsor

Sun Yat-sen University

Sponsor institution

Qilu Pharmaceutical Co., Ltd.

Collaborator