A pilot study of personalized biomarker-based treatment strategy or immunotherapy in patients with recurrent/metastatic squamous cell carcinoma of the head and neck UPSTREAM - A pilot study on personalized medicine for patients with recurrent or metastatic head and neck cance

EORTC AISBL/IVZW0 个研究点目标入组 340 人2021年6月17日

概览

暂无简介。

注册库

who.int

开始日期

2021年6月17日

结束日期

待定

最后更新

4年前

研究类型

Interventional clinical trial of medicinal product

性别

All

发起方

EORTC AISBL/IVZW

•1\- General inclusion criteria
•Histologically confirmed recurrent and/or metastatic SCCHN of the oral cavity, oropharynx, hypopharynx or larynx not amenable to curative treatment.
•At least one measurable lesion by MRI or CT\-scan according to RECIST 1\.1, evaluated within 2 weeks prior to registration.
•Progressive disease after first line platinum\-based chemotherapy with or without cetuximab given as palliative treatment or progressive disease within 1 year if platinum\-based chemotherapy was given as a part of the multimodal curative treatment.
•ECOG performance status 0 \-1\.
•Tumor core biopsy from any accessible tumor site available for central testing.
•Patients must have adequate organ function, evaluated within 14 days prior to cohort allocation:
•Hemoglobin \= 9 g/100 ml,
•Neutrophils \= 1,500/mm3,
•Platelets \= 100,000/mm3,

•1 \- General exclusion criteria
•Unresolved and significant toxicity CTCAE version 4\.03 grade \= 2 from previous anticancer therapy other than alopecia.
•History of any of the following cardiovascular conditions within 6 months prior to registration:
•myocardial infarction,
•severe/unstable angina,
•ongoing cardiac dysrhythmias of CTCAE version 4\.03 Grade 2 or more,
•atrial fibrillation of any grade,
•coronary/peripheral artery bypass graft,
•symptomatic congestive heart failure according to NYHA Class III or Class IV,
•Significant active cardiac disease including uncontrolled high blood pressure according to the CTCAE v 4\.03 grade 3\.