NCT05385926

Combining RT With Immunotherapy and Chemotherapy in Metastatic Nasopharyngeal Carcinoma

A Phase II Study: Safety and Efficacy of Combining Radiation Therapy With Immunotherapy and Chemotherapy in de Novo Metastatic Nasopharyngeal Carcinoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 34 (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

Incidences of de novo metastatic nasopharyngeal carcinoma range from 6% to 8% at the time of presentation. For the initial diagnosis of metastatic NPC, PD-1 plus chemotherapy yields a satisfactory outcome with1year PFS of 40%. Previous study demonstrated the benefit of adding radiotherapy to chemotherapy in metastatic NPC, however there is no evidence whether radiotherapy can further improve PFS based on chemotherapy plus PD-1 . The purpose of this study is to evaluate the safety and effectiveness of first-line immunochemotherapy combined with radiotherapy for initial diagnosed metastatic NPC.

Conditions

• Metastatic Nasopharyngeal Cancer

Interventions

Type	Name	Description
RADIATION	Radiotherapy	Patients who had complete response or partial response after at least 3 cycles (no more than 6 cycles) of chemotherapy combined with immunotherapy receive local radiotherapy 21 days. For those non-CR oligo-metastatic disease or symptomatic lesion, SBRT or conventional RT delivered. Maintenance therapy of immunotherapy for 2 years.

Timeline

• Start date: 2022-05-05
• Primary completion: 2024-04-30
• Completion: 2024-04-30
• First posted: 2022-05-23
• Last updated: 2024-02-05

Locations

1 site across 1 country: China