| Eligibility |
Inclusion Criteria:
1. =18 years old and =60 years old;
2. Pathologically confirmed nasopharyngeal carcinoma;
3. Patients with primary locally advanced non-metastatic nasopharyngeal carcinoma who
were eligible for standard concurrent radiotherapy and chemotherapy were in line with
stage III and IVA defined by the International Union against Cancer and American Joint
Commission on Cancer (UICC/AJCC) staging System (version 8) (note: Stage III only
included EBV-DNA>1×10^4 copy/mL).
4. Patients with locally advanced nasopharyngeal carcinoma who have not received prior
radiotherapy or chemotherapy for the disease in this study;
5. Karnofsky functional status score should be at least 70 points (the decline of
functional status score caused by tumor should be appropriately relaxed after the
judgment of the researcher, and the minimum score should be no less than 50 points. );
6. At least 1 measurable lesion according to RECIST1.1 assessment criteria, measurable
lesion should not have received local treatment such as radiotherapy;
7. Expected survival =3 months;
8. The function of vital organs meets the following requirements (not allowed within 14
days before screening . May use any blood components, cell growth factors, leukoplast,
platelets Drugs, anemia correction drugs) :
- Neutrophil absolute count (ANC) =1.5×109/L
- Platelet =100×109/L;
- Hemoglobin =8.0g/ dL (note: Hemoglobin =8.0g/ dL can be achieved through blood
transfusion or other intervention);
- Serum albumin =2.8g/dL;
- Bilirubin = 1.5x ULN, ALT and AST= 1.5x ULN; ALT and AST= 5x ULN if liver
metastasis was present;
- creatinine clearance =50mL/min
9. Women of non-surgical sterilization or reproductive age and sexually active men
enrolled in the study are required to use a medically effective form of contraception
(such as an intrauterine device [IUD], birth control pills or condoms) for the
duration of the study treatment and for at least 3 months after the last use of Tamfu
and for at least 6 months after the last use of chemotherapy; The serum or urine HCG
test of female patients of reproductive age who were not undergoing surgical
sterilization must be negative within 7 days prior to study enrollment. And must be
non lactation period; 10 Informed consent has been signed. -
Exclusion Criteria:
1. Have a history of allergy to 5-FU, cisplatin and tumor necrosis factor;
2. Previous treatment related to tumor necrosis factor (TNF);
3. Major surgery other than nasopharyngeal cancer was diagnosed within 28 days prior to
randomization or major surgery was expected during the study period;
4. The subject has any active autoimmune disease or a history of autoimmune disease
(e.g., but not limited to: interstitial pneumonia, uveitis, enteritis, hepatitis,
hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism); Subjects with
vitiligo or asthma in complete remission during childhood without any intervention as
adults could be included; Subjects with asthma requiring medical intervention with
bronchodilators were excluded);
5. Subject is taking immunosuppressants, or systemic, or absorbable sites Hormone therapy
to achieve immunosuppression (dose >10mg/ day prednisone or Other equally effective
hormones) and continued to be used within 2 weeks prior to enrollment.
6. The subject has previous or co-existing malignancies (except those that have been
cured and survived for more than 5 years without cancer, such as basal cell carcinoma
of the skin, carcinoma in situ of the cervix and papillary carcinoma of the thyroid);
7. Patients with cardiac clinical symptoms or diseases that are not well controlled, such
as: ? HEART failure of NYHA grade 2 or above ? unstable angina pectoris ? myocardial
infarction within 1 year ? clinically significant ventricular arrhythmias or
ventricular arrhythmias requiring treatment or intervention;
8. Subjects have active infection or have unexplained fever >38.5 degrees during
screening but before the first dose (the investigator judged that the subjects' fever
due to tumor could be included in the study);
9. Subjects with congenital or acquired immune deficiency (e.g. HIV infected), or active
hepatitis (reference: HBsAg, anti-HBS, HBeAg, anti-HBC, anti-HBE, HBV DNA=104/ml,
liver cell transaminase, etc.); Hepatitis C reference: HCV antibodies and HCVRNA);
10. The subject has a known history of psychotropic drug abuse, alcoholism or drug abuse;
11. In the judgment of the researcher, the subject has other factors that may lead to the
termination of the study, such as other serious diseases (including mental diseases)
requiring combined treatment, serious abnormal laboratory examination, family or
social factors, which may affect the safety of the subject, or the collection of test
data and samples.
12. Women who are pregnant or breastfeeding, or who refuse/cannot accept medically
acceptable conditions. For women with potential pregnancy and sexually active men.
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