Clinical trial NCT03196869: the Study of Effect of Chronomodulated Chemotherapy on the Dendritic Cells Subsets in the Treatment of Advanced Nasopharyngeal Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Locally Advanced Head and Neck Squamous Cell Carcinoma
Keywords: NPC peripheral blood dendritic cell chronic-chemotherap
Lead sponsor: Guiyang Medical University
Sponsor class: OTHER
First posted: 2017-06-23
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Eligibility criteria: 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.

Primary outcomes:
measure: Dendritic cell subgroup changes of Participants
timeFrame: termination of treatment, 3 months after treatment
Secondary outcomes:
measure: Number of Participants with curative effect
timeFrame: 1 year
measure: Number of Participants with Adverse Events as a Measure of Safety
timeFrame: 5 year
Other outcomes:
measure: Progression-free survival
timeFrame: 5 years
measure: Overall survival
timeFrame: 5 years
Locations:
city: Guiyang
country: China
facility: Cancer Hospital of Guizhou Medical University
state: Guizhou
Study officials:
affiliation: Guizhou Provincial Cancer Hospital
name: Feng Jin, Bachelor
role: STUDY_CHAIR
References: