NCT06509009

Nimotuzumab Combined With TGP as First-line Therapy in Patients With Recurrent/Metastatic Nasopharyngeal Carcinoma

Nimotuzumab Combined With Toripalimab/Gemcitabine/Cisplatin as First-line Therapy in Patients With Recurrent/Metastatic Nasopharyngeal Carcinoma: a Prospective, Single-arm, Phase II Clinical Study

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The goal of this study is to learn the efficacy and safety of nimotuzumab combined with toripalimab and gemcitabine/cisplatin regimen treatment recurrent/distant-metastasis nasopharyngeal carcinoma.

Detailed description

The study is to investigate the efficacy and safety of combining nimotuzumab and toripalimab with the GP regimen for first line recurrent/distant metastasis nasopharyngeal carcinoma. This clinical trial adopts a single-center, prospective, single-arm phase II trial design. Each treatment cycle will be three weeks long, the chemotherapy regimen contains no more than 6 circles, nimotuzumab and toripalimab were used until progression. After screening, eligible patients will be enrolled in the study. Patients will receive up to 6 cycles of nimotuzumab and toripalimab, gemcitabine, cisplatin therapy. Patients will undergo regular follow-up visits, and researchers will collect data on efficacy and safety. Short-term outcomes will be assessed according to the RECIST 1.1 criteria/irRECIST, and adverse events will be evaluated using the CTCAE 5.0.

Conditions

• Nasopharyngeal Carcinoma by AJCC V8 Stage

Interventions

Type	Name	Description
DRUG	Nimotuzumab	nimotuzumab, toripalimab, gemcitabine, cisplatin

Timeline

• Start date: 2024-08-30
• Primary completion: 2026-05-30
• Completion: 2027-05-30
• First posted: 2024-07-19
• Last updated: 2025-09-19

Locations

1 site across 1 country: China