Study of TQB2450 in Patients With Recurrent or Metastatic Squamous Cell Cancer of the Head and Neck(R/M SCCHN)

PHASE3UnknownINTERVENTIONAL
Enrollment

334

Participants

Timeline

Start Date

June 11, 2019

Primary Completion Date

December 31, 2020

Study Completion Date

May 30, 2021

Conditions
Squamous Cell Carcinoma of the Head and Neck
Interventions
DRUG

TQB2450+cisplatin or carboplatin + 5-Fluorouracil (5-FU)

TQB2450 1200mg IV ,cisplatin 75 mg/m\^2 IV or carboplatin AUC 5 IV on Day 1 of each week in 3-week cycles (6 cycle maximum); plus 5-FU 750 mg/m\^2/day IV continuous from Day 1-5 of each 3- week cycle (6 cycle maximum).

DRUG

placebo+cisplatin or carboplatin + 5-Fluorouracil (5-FU)

placebo 1200mg IV ,cisplatin 75 mg/m\^2 IV or carboplatin AUC 5 IV on Day 1 of each week in 3-week cycles (6 cycle maximum); plus 5-FU 750 mg/m\^2/day IV continuous from Day 1-5 of each 3- week cycle (6 cycle maximum).

Trial Locations (1)

Unknown

RECRUITING

Shanghai East Hospital, Shanghai

All Listed Sponsors
lead

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

INDUSTRY