NCT04830267

The Efficacy of Camrelizumab Plus Stereotactic Body Radiotherapy in R/M NPC

A Phase II Randomized Trial of Camrelizumab With Stereotactic Body Radiotherapy Versus Camrelizumab Alone in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 39 (estimated)
• Sponsor: Chongqing University Cancer Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Camrelizumab is an antibody targeting programmed death receptor 1 (PD-1) and its ligand programmed death-ligand 1 (PD- L1) that is designed to boost the immune system. It does this by allowing immune cells to fight the cancer. Stereotactic body radiotherapy is a potential immunostimulatory therapy that may amplify antitumor response when combined with camrelizumab.

Detailed description

All eligible patients from 3 hospitals will be equally randomized between the 2 following treatment groups: Standard treatment group: Camrelizumab 200mg IV every 2 weeks. Experimental group: Stereotactic body radiotherapy 27Gy/3F and Camrelizumab 200mg IV every 2 weeks.

Conditions

• Nasopharyngeal Carcinoma

Interventions

Type	Name	Description
DRUG	Camrelizumab	Camrelizumab 200mg IV starting day 1 and then every 2 weeks thereafter. Treatment with Camrelizumab will continue until progression or unacceptable toxicity.
RADIATION	Stereotactic body radiotherapy	Image guided, stereotactic body radiotherapy (27 Gy over 3 fractions given every other day) to a single lesion to start by study day 14 (study day 1 is day of first dose of Camrelizumab).

Timeline

• Start date: 2021-03-01
• Primary completion: 2024-08-01
• Completion: 2026-08-01
• First posted: 2021-04-05
• Last updated: 2024-03-28

Locations

3 sites across 1 country: China