[Translation] A randomized, open-label, parallel-controlled, multicenter Phase Ib/II clinical trial to evaluate the efficacy and safety of TQB3728 tablets in patients with locally advanced head and neck tumors receiving concurrent chemoradiotherapy.
Ib期剂量递增阶段:
主要目的
评价TQB3728片在非手术治疗的局部晚期头颈部肿瘤同期放化疗患者的安全性和耐受性,并确定II期推荐剂量(RP2D)
次要目的
评价TQB3728片在非手术治疗的局部晚期头颈部肿瘤同期放化疗患 的初步疗效 ,以及口服给药的药代动力学(PK)特征 II期剂量扩展阶段:
主要目的
评价TQB3728片在非手术治疗的局部晚期头颈鳞癌(SCCHN)同期放化疗患者中初步疗效
次要目的
评价TQB3728片在非手术治疗的局部晚期头鳞癌(SCCHN)同期放化疗患者中的安全性
探索性目的
探索TQB3728片治疗非手术治疗的局部晚期头颈腺癌同期放化疗患者中初步疗效和安全性
[Translation] Phase Ib dose escalation phase:
Primary purpose
To evaluate the safety and tolerability of TQB3728 tablets in patients with non-surgical treatment of locally advanced head and neck tumors undergoing concurrent chemoradiotherapy, and to determine the Phase II recommended dose (RP2D)
Secondary purpose
To evaluate the preliminary efficacy of TQB3728 tablets in patients with non-surgical treatment of locally advanced head and neck tumors undergoing concurrent chemoradiotherapy, as well as the pharmacokinetic (PK) characteristics of oral administration Phase II dose expansion phase:
Primary purpose
To evaluate the preliminary efficacy of TQB3728 tablets in patients with non-surgical treatment of locally advanced head and neck squamous cell carcinoma (SCCHN) undergoing concurrent chemoradiotherapy
Secondary purpose
To evaluate the safety of TQB3728 tablets in patients with non-surgical treatment of locally advanced head and neck squamous cell carcinoma (SCCHN) undergoing concurrent chemoradiotherapy
Exploratory purpose
To explore the preliminary efficacy and safety of TQB3728 tablets in patients with non-surgical treatment of locally advanced head and neck adenocarcinoma undergoing concurrent chemoradiotherapy