NCT06414577

Irinotecan Liposomes in Combination With Nituzumab for the Treatment of Recurrent/Metastatic Nasopharyngeal Carcinoma After Failure of First-Line or Higher Immunotherapy

A Single-Arm Phase II Clinical Study of Irinotecan Liposomes in Combination With Nituzumab for the Treatment of Recurrent/Metastatic Nasopharyngeal Carcinoma After Failure of First-Line or Higher Immunotherapy

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: XIANG YANQUN · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Nasopharyngeal cancer is a malignant tumor that arises from the cells of the nasopharyngeal epithelium, with its occurrence spread across different regions worldwide. Recent data from China in 2015 revealed approximately 6.0 million new cases of nasopharyngeal cancer, leading to approximately 34,000 deaths. When choosing a chemotherapy regimen for patients with metastatic nasopharyngeal cancer, the gemcitabine and cisplatin combination (GP) is typically recommended as the initial treatment. However, it is common for patients to experience disease progression after receiving first-line chemotherapy, highlighting the importance of a well-defined second-line treatment plan. Recent clinical studies have indicated that combining nituzumab with radiotherapy can enhance treatment efficacy with minimal side effects, providing promising results for advanced nasopharyngeal cancer patients. Additionally, the use of irinotecan liposome injection has proved beneficial in modifying the drug's pharmacokinetics, resulting in improved drug delivery to the tumor site while reducing toxicity in healthy tissues. This study aims to explore the effectiveness and safety of combining irinotecan liposome with nituzumab treatment for recurrent metastatic nasopharyngeal carcinoma that has not responded to initial immunotherapy. Participants selected for this clinical trial will receive a treatment regimen consisting of liposomal irinotecan administered intravenously at a dose of 70 mg/m2 on day 1, along with nituzumab given at a dose of 400 mg via intravenous injection on the same day. This treatment cycle will be repeated every two weeks for a maximum of eight cycles, or until disease progression, intolerable side effects, or other criteria necessitating discontinuation of treatment as determined by the investigator. By evaluating the efficacy and safety of this combined regimen, investigators aim to establish a novel therapeutic approach for managing advanced nasopharyngeal carcinoma in the context of current immunotherapy advancements.

Conditions

• Nasopharyngeal Cancer

Interventions

Type	Name	Description
DRUG	Irinotecan Liposomal combined With Nituzumab	Irinotecan liposomal: 70mg/m2, ivgtt, d1; Nituzumab: 400 mg, igvtt, d1 One treatment cycle every two weeks for up to 8 cycles, or until disease progression, intolerable toxicity, death, and investigator judgment of no further benefit

Timeline

• Start date: 2024-05-22
• Primary completion: 2025-03-23
• Completion: 2025-03-23
• First posted: 2024-05-16
• Last updated: 2024-12-30

Locations

1 site across 1 country: China