NCT05513573View on ClinicalTrials.gov

Phase II Clinical Study to Compare the Efficacy and Safety of HLX07 + Serplulimab +Chemotherapy Versus Placebo + Serplulimab + Chemotherapy in First-Line Treatment of Patients With Recurrent or Metastatic NPC

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

75

Participants

Timeline

Start Date

December 14, 2022

Primary Completion Date

September 30, 2024

Study Completion Date

September 30, 2026

Conditions
Nasopharyngeal Carcinoma by AJCC V8 Stage
Interventions
DRUG

HLX07

1500 mg, D1，Q3W

DRUG

HLX10

300 mg, D1, up to 2 years,Q3W

DRUG

placebo

1500 mg, D1，Q3W

DRUG

chemotherapy

gemcitabine 1000 mg/m2, D1,D8; cisplatin 80 mg/m2,D1；Q3W, up to 6 cycles

Trial Locations (1)

510060

Sun Yat-sen University Cancer Center, Guanzhou

All Listed Sponsors
lead

Shanghai Henlius Biotech

INDUSTRY