Based on the application prospect of rmh-TNF combined with chemotherapy in the treatment of solid tumors. In this study, cisplatin combined with low dose 5-FU was proposed to enhance the immune function of 5-FU. Tianenfu is a novel recombinant modified human tumor necrosis with high activity and low toxicity. The fact that RMH-TNF has the potential of better in vivo efficacy and clinical antitumor effect. Therefore, the study was designed to investigate the treatment of concurrent chemoradiotherapy combined with TNF versus concurrent chemoradiotherapy combined with placebo for the efficacy and safety of advanced nasopharyngeal carcinoma.
≥18 years old and ≤60 years old;
Pathologically confirmed nasopharyngeal carcinoma;
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).
Patients with locally advanced nasopharyngeal carcinoma who have not received prior radiotherapy or chemotherapy for the disease in this study;
Have a history of allergy to 5-FU, cisplatin and tumor necrosis factor;
Previous treatment related to tumor necrosis factor (TNF);
Major surgery other than nasopharyngeal cancer was diagnosed within 28 days prior to randomization or major surgery was expected during the study period;
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);
Parallel
5-fu
Drug5-fu: 200mg/m2/d, continuous intravenous infusion on the 1st to 30th day of each cycle.
Cisplatin
DrugCisplatin: 80mg/m2, used on the 1st and 28th day of each cycle.
Radiotherapy
RadiationRadiotherapy: Radiotherapy was initiated on day 15 of the first cycle of chemotherapy . GTV: 6810cGy (227 cGy/30f) Or 6996 cGy (212 cGy/ 33F); CTV: 5400-6000 cGy (180-200 cGy/f); Radiotherapy once a day, 5 times a week, a total of 30-33 times, a total of about 6 weeks.
TNF
DrugTNF (recombinant human tumor necrosis factor for injection) : 1 million IU (BSA\<2.0m2) or 1.5 million IU (BSA≥2.0m2), dissolved in normal saline 1-2mL, intramuscular, QD, 30 days in the first and third months, once a day.
Placebo
DrugPlacebo: 1-2ml normal saline, intramuscular injection, QD, once a day, 30 days in the first and third months.
OS
Overall survival Overall survival Overall survival Overall survival Overall survival Overall survival Overall survival Overall survival
PFS
Progression-free survival
Severe drug-related adverse events
grade III-V according to CTCAE v4.0
ORR
Objective response rate
DCR
Disease control rate
DOR
Duration of response
Drug-related adverse events grade I-II
Minor drug-related adverse events grade I-II according to CTCAE v4.0
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Sun Yat-sen University
Lead sponsor
Shanghai Weike Bioscience Co., Ltd.
Collaborator
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