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

Phase 2UnknownNCT03196869

Guiyang Medical University128 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

128

Conditions

Locally Advanced Head and Neck Squamous Cell Carcinoma

Interventions

Chrono-chemotherapyDEVICE

Chrono-chemotherapy+concurrent radiochemotherapy

Routine intravenous dripDEVICE

Routine intravenous drip-chemotherap

induction Chrono-chemotherapyDRUG

Experimental group:docetaxel,cisplatin,5-FU

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (1)

Cancer Hospital of Guizhou Medical University

Guiyang, Guizhou, China

RECRUITING

Outcomes

Primary Outcomes

Dendritic cell subgroup changes of Participants

By flow cytometry detection of two groups of peripheral blood dendritic cells subsets and lymphocyte subpopulation changes before and after the radiation and chemotherapy

Time frame: termination of treatment, 3 months after treatment

Secondary Outcomes

Number of Participants with curative effect

Evaluate the immediate effect at 1year after Concurrent chemo-radiotherapy by RECIST

Time frame: 1 year

Number of Participants with Adverse Events as a Measure of Safety

To assess and record nausea, vomiting, oral mucositis, diarrhea and other adverse drug reactions by CTC 4.0

Time frame: 5 year

Central Contacts

Feng Jin, Bachelor

CONTACT

0851-86512802 jinf8865@yeah.net

Juan Li, Bachelor

CONTACT

0851-86512802 1348330985@qq.com

Data from ClinicalTrials.gov

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