172
Participants
Start Date
July 1, 2022
Primary Completion Date
July 1, 2024
Study Completion Date
July 1, 2029
5-fu
5-fu: 200mg/m2/d, continuous intravenous infusion on the 1st to 30th day of each cycle.
Cisplatin
Cisplatin: 80mg/m2, used on the 1st and 28th day of each cycle.
Radiotherapy
Radiotherapy: 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
TNF (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
Placebo: 1-2ml normal saline, intramuscular injection, QD, once a day, 30 days in the first and third months.
Shanghai Weike Bioscience Co., Ltd.
UNKNOWN
Sun Yat-sen University
OTHER