NCT03196869

the Study of Effect of Chronomodulated Chemotherapy on the Dendritic Cells Subsets in the Treatment of Advanced Nasopharyngeal Cancer

Phase II Clinical Randomized Study of the Effect of Chronomodulated Chemotherapy Followed by Concurrent IMRT Chemo-radiotherapy on the Dendritic Cells Subsets and Immunity in the Treatment of Advanced Nasopharyngeal Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 128 (estimated)
• Sponsor: Guiyang Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study is to observe and compare the effect of docetaxel plus lobaplatin induction chemotherapy combined with lopoplatin chemoradiotherapy and TPF induction chemotherapy combined with cisplatin chemoradiotherapy on dendritic cells subsets in the treatment of locally advanced head and neck squamous cell carcinoma.

Detailed description

TPF program is currently the local advanced head and neck squamous cell carcinoma commonly used inducing chemotherapy, cisplatin is the preferred drug for the same period chemotherapy.Dendritic cells (DC) play an essential role in the induction and regulation of immune responses.The effect of radiation and chemotherapy is closely related to the patients' immune function.In this study, Phase II clinical trials were performed. Patients with locally advanced head and neck squamous cell carcinoma were randomly divided into experimental group and control group. The trial group was treated with docetaxel + lorosine-induced chemotherapy combined with lorplatin concurrent radiotherapy and chemotherapy. The control group was treated with TPF Cisplatin concurrent chemotherapy, observed the relationship between dendritic cells subsets and clinical prognosis of patients, to provide a new method for the treatment of locally advanced nasopharyngeal carcinoma and technical support

Conditions

• Locally Advanced Head and Neck Squamous Cell Carcinoma

Interventions

Type	Name	Description
DEVICE	Chrono-chemotherapy	Chrono-chemotherapy+concurrent radiochemotherapy
DEVICE	Routine intravenous drip	Routine intravenous drip-chemotherap
DRUG	induction Chrono-chemotherapy	Experimental group:docetaxel,cisplatin,5-FU
DRUG	induction Routine-chemotherapy	control group:docetaxel,cisplatin,5-FU
DRUG	cisplatin chrono-chemotherapy	Experimental group: cisplatin chrono-chemotherapy
DRUG	cisplatin routine-chemotherapy	control group:cisplatin routine-chemotherapy
RADIATION	intensity-modulated radiation therapy	control group is similar to Experimental group

Timeline

• Start date: 2017-04-07
• Primary completion: 2019-04-12
• Completion: 2022-08-12
• First posted: 2017-06-23
• Last updated: 2017-06-23

Locations

1 site across 1 country: China