NCT06561763

TPC VS. GP Induced Chemotherapy Combined With Nimotuzumab and Toripalimab in the Treatment of Locally Advanced Nasopharyngeal Carcinoma

TPC Versus GP Induced Chemotherapy Combined With Nimotuzumab and Toripalimab in the Treatment of Localized Advanced Nasopharyngeal Carcinoma:Multi Center, Open Label, Randomized Controlled, Non Inferiority Design, Phase III Clinical Study

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 416 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

We expect to conduct a clinical trial in high-risk locally advanced nasopharyngeal carcinoma patients to explore the efficacy and safety of sequential radical radiotherapy treatment after induction chemotherapy (TPC vs. GP) with combination therapy of nivolumab and triprolizumab.

Conditions

• High Risk Locally Advanced Nasopharyngeal Carcinoma

Interventions

Type	Name	Description
DRUG	Nimotuzumab,Toripalimab，Cisplatin, albumin paclitaxel, capecitabine	Albumin paclitaxel 200g/m2, intravenous drip administration, d1; Cisplatin 60 mg/m2， Intravenous , d1; Capecitabine, 1000mg/m2, orally administered D1-14； Triprolizumab injection 240mg, intravenous D1; Nivolumab 400mg, intravenous D1; Q3W 1 cycle, 3 cycles Period, 3 weeks in total
DRUG	Nimotuzumab,Toripalimab，Cisplatin, Gemcitabine	Cisplatin 80 mg/m2， Intravenous drip administration, d1; Gemcitabine, 1000mg/m2,Intravenous ，D1,D8； Triprolizumab injection 240mg, intravenous ； Nivolumab 400mg, intravenous； Q3W 1 cycle, 3 cycles

Timeline

• Start date: 2024-08-20
• Primary completion: 2028-08-20
• Completion: 2031-08-20
• First posted: 2024-08-20
• Last updated: 2024-08-20