NCT06331845

Stop and go Strategy as First-line Treatment for Widely Metastatic Nasopharyngeal Carcinoma

Stop and go Strategy as First-line Treatment in Patients With Objective Response After Systematic Chemotherapy for Widely de Novo Metastatic Nasopharyngeal Carcinoma: A Phase II Trial

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 39 (estimated)
• Sponsor: Fujian Cancer Hospital · Other Government
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study aimed to investigate the value of a novel strategy of intermittent systematic chemotherapy (ISC) in widely metastatic nasopharyngeal carcinoma (wmNPC) patients who achieve objective response after systematic chemotherapy (SC).

Detailed description

Widely metastatic nasopharyngeal carcinoma (wmNPC) represented a particular subgroup of patients with the worst prognosis, of which palliative systematic chemotherapy(SC) was recommended as initial treatment, however, palliative systematic treatment was often required to be stopped due to the cumulative toxicities while stopping SC may lead to disease progression, a 'stop and go' approach, namely chemotherapy 'holidays', was a new strategy which may keep a good balance of benefit and risk. This study aimed to investigate the value of a novel strategy of intermittent systematic chemotherapy (ISC) in wmNPC patients who achieve objective response after SC.

Conditions

• Metastatic Nasopharyngeal Carcinoma
• Intermittent Systematic Chemotherapy

Interventions

Type	Name	Description
DRUG	Gemcitabine	1000 mg/m2 on Days 1 and 8
DRUG	Cisplatin	a total of 80-100 mg/m2 for d1-3
DRUG	Paclitaxel protein-bound	260 mg/m2 on Day 1
DRUG	Capecitabine	a dose of 1-1.25 g/m2 twice daily in in 2 weeks for one cycle
DRUG	Tislelizumab	200 mg on Day 1

Timeline

• Start date: 2024-05-01
• Primary completion: 2026-05-01
• Completion: 2028-05-01
• First posted: 2024-03-26
• Last updated: 2024-03-26