NCT05290194

Radiotherapy Combined With PD-1 Monoclonal Antibody and Capecitabine in the Treatment of Nasopharyngeal Carcinoma

Multi-target Radiotherapy Combined With PD-1 Monoclonal Antibody and Capecitabine Maintenance Therapy Treating Oligometastatic Nasopharyngeal Carcinoma: a Single-arm, Multicenter, Prospective, Open-label Phase II Clinical Trial

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 28 (estimated)
• Sponsor: Fifth Affiliated Hospital, Sun Yat-Sen University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a single-arm, multicenter, prospective, open-label phase II clinical trial of multi-target radiotherapy combined with PD-1 monoclonal antibody and capecitabine maintenance therapy treating oligometastatic nasopharyngeal carcinoma, the main purpose of which is to evaluate the efficacy of multi-target radiotherapy combined with PD-1 monoclonal antibody and capecitabine maintenance therapy regimen in treating oligometastatic nasopharyngeal carcinoma.

Detailed description

This is a single-arm, multicenter, prospective, open-label phase II clinical study of multi-target radiotherapy combined with PD-1 monoclonal antibody and capecitabine maintenance therapy for oligometastatic nasopharyngeal carcinoma. Its primary objective is to assess the efficacy, including progression-free survival (PFS), 2-year overall survival (Two-year OS) and progression-free survival (Two-year PFS), overall survival (OS), duration of response (DOR) and safety of multi-target radiotherapy combined with PD-1 monoclonal antibody and capecitabine maintenance therapy in treating oligometastatic nasopharyngeal carcinoma. The secondary objective is to explore the potential genetic biomarkers and clinical therapeutic efficacy evaluation and prediction model of multi-target radiotherapy combined with PD-1 monoclonal antibody and capecitabine maintenance therapy regimen in treating oligometastatic nasopharyngeal carcinoma, providing the evidence of the screening of the potential patients benefiting from the regimen of this trial.

Conditions

• Radiotherapy
• PD-1 Inhibitor
• Capecitabine
• Nasopharyngeal Carcinoma

Interventions

Type	Name	Description
RADIATION	SBRT radiotherapy + Conventionally fractionated radiotherapy	Radiotherapy was performed 3-6 weeks after the end of first-line treatment, followed by conventional fractionated radiotherapy of the primary tumor and cervical lymph node metastases, SBRT radiotherapy of distant organ metastases 3-6 weeks later.
DRUG	PD-1 inhibitor	Immunotherapy of PD-1 inhibitor is used during the whole time of this trial until subjects were withdrawn from the trial or the trial complete
DRUG	Capecitabine	Capecitabine is treated for patients 3-6 weeks after radiotherapy, which combines with PD-1 inhibitor as the maintenance regimen in the trial.

Timeline

• Start date: 2022-03-28
• Primary completion: 2026-12-01
• Completion: 2027-01-01
• First posted: 2022-03-22
• Last updated: 2022-04-14

Locations

1 site across 1 country: China