This Phase II study is a clinical trial exploring the efficacy and safety of BL-B01D1 with or without PD-1 monoclonal antibody in patients with high-risk locally advanced nasopharyngeal carcinoma.
No gender restriction;
Age: ≥18 years and ≤75 years;
Expected survival time ≥3 months;
Pathologically confirmed as newly diagnosed nasopharyngeal carcinoma with "non-keratinizing carcinoma (WHO criteria)";
Prior receipt of any anti-tumor systemic therapy regimen for nasopharyngeal carcinoma；
Use of modern traditional Chinese medicine preparations that have been approved by the NMPA for anti-tumor therapy within 2 weeks prior to the first dose；
History of severe cardiac or cerebrovascular disease；
Prolonged QTc interval, complete left bundle branch block, second- or third-degree atrioventricular block, or frequent and uncontrolled arrhythmias；
Parallel
BL-B01D1
DrugAdministration by intravenous infusion for a cycle of 3 weeks.
PD-1 monoclonal antibody
DrugAdministration by intravenous infusion for a cycle of 3 weeks.
Gemcitabine
DrugAdministration by intravenous infusion for a cycle of 3 weeks.
Cisplatin
DrugAdministration by intravenous infusion for a cycle of 3 weeks.
Complete Response Rate(CRR)
Post-induction therapy complete response rate will be investigated.
Overall Survival (OS)
Overall survival (OS) is defined as the time between the day the subject is randomized and the subject's death.
Event-free Survival(EFS)
Event-free Survival will be investigated.
Distant Metastasis-free Survival(DMFS)
Distant Metastasis-free Survival will be investigated.
Locoregional Recurrence-free Survival(LRRFS)
Locoregional Recurrence-free Survival will be investigated.
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Sichuan Baili Pharmaceutical Co., Ltd.
Lead sponsor
Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
