A phase I trial testing TH-302, a tumor-selective Hypoxia-Activated cytotoxic Prodrug, in combination with preoperative chemoradiotherapy in patients with distal esophageal and esophago-gastric junction adenocarcinoma - TH-302 in esophagal cancer

Medisch Universitair Ziekenhuis Maastricht0 个研究点目标入组 18 人开始时间: 待定最近更新: 2024年2月28日

适应症

试验速览

暂无简介。

•*Histologically proven adenocarcinoma of the esophagus
•*Age>18 years
•*UICC T2-4 N0-2 M0, potentially resectable disease
•*Patient discussed at tumour board (multidisciplinary team meeting)
•*No evident tumor invasion in nearby regions like aorta, trachea
•*WHO performance status 0-2
•*Less than 10 % weight loss the last 6 months
•*Laboratory requirements within 7 days prior to enrollment (start chemoradiotherapy):
•Haemotology: haemoglobin >10g/dl, absolute neutrophils * 1.5 x 109/L,platelets * 100x109/L
•Biochemistry:bilirubin within normal limits, AST(SGOT)/ALT (SGPT) * 2.5 institutional upper limit, Creatinine clearance * 60 ml/min.
•*Willing and able to comply with the study prescriptions
•*No history of prior thoracic radiotherapy
•*No severe chronic obstructive pulmonary disease with hypoxemia or in the opinion of the investigator any physiological state leading to hypoxemia
•*Women should not be pregnant or lactating
•*No known infection with HIV, hepatitis B or C or any other active infection
•*Normal ECG with careful evaluation of QT/QTc
•*Have given written informed consent before patient registration

•*Recent (< 3 months) severe cardiac disease (arrhythmia, congestive heart failure, infarction)
•*Patients with difficult peripheral intravenous access
•*History of prior thoracic radiotherapy
•*Severe chronic obstructive pulmonary disease with hypoxemia or in the opinion of the investigator any physiological state leading to hypoxemia
•*Women who are pregnant or lactating
•*Known infection with HIV, hepatitis B or C or any other active infection

发起方

Medisch Universitair Ziekenhuis Maastricht