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

Guiyang Medical University

Status and phase: Unknown; Phase 2

Conditions: Locally Advanced Head and Neck Squamous Cell Carcinoma

Treatments: Radiation: intensity-modulated radiation therapy; Drug: cisplatin chrono-chemotherapy; Device: Chrono-chemotherapy; Drug: induction Routine-chemotherapy; Drug: cisplatin routine-chemotherapy; Device: Routine intravenous drip; Drug: induction Chrono-chemotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03196869

201708112121

Details and patient eligibility

About

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.

Full 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

Enrollment: 128 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. initial treatment of advanced nasopharyngeal carcinoma Ⅲ-Ⅳ patients with pathologically confirmed (according to 2010 UICC staging, T3-4, N0-3), without evidence of distant metastasis (M0). Have measurable tumor lesions.
2. KPS≥70 points.
3. the age of 18-70 years old, male or female.
4. no major organ dysfunction; normal bone marrow function (WBC ≥4.0 × 109 / L, platelets ≥100 × 109 / L, hemoglobin ≥90g / L), normal liver function (total bilirubin, alanine aminotransferase, aspartate aminotransferase ≤1.5 times the upper limit of normal), normal renal function (creatinine ≤ 1.5 times upper limit of normal).
5. understand this study and signed informed consent

Exclusion criteria

1. Three months in the use of Chinese herbal medicine or immune modulators
2. distant metastasis.
3. who had received prior chemotherapy.
4. patients have physical or mental illness, and by researchers believe that patients can not be completely or fully understood in this study possible complications.
5. pregnancy (via the urine or serum β-HCG test confirmed) or during lactation. serious complications, such as uncontrolled hypertension, heart failure, diabetes and so on.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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128 participants in 2 patient groups

Chrono-chemotherapy group

Experimental group

Description:

Induction chrono-chemotherapy followed by cisplatin chrono-chemotherapy concurrent combined with intensity-modulated radiation therapy;Delivery time is different from the control group

Treatment:

Drug: induction Chrono-chemotherapy

Radiation: intensity-modulated radiation therapy

Drug: cisplatin chrono-chemotherapy

Device: Chrono-chemotherapy

Routine intravenous drip

Other group

Description:

control group:Induction routine-chemotherapy followed by cisplatin routine-chemotherapy concurrent combined with intensity-modulated radiation therapy

Treatment:

Radiation: intensity-modulated radiation therapy

Drug: cisplatin routine-chemotherapy

Device: Routine intravenous drip

Drug: induction Routine-chemotherapy