EUCTR2017-000086-74-IT进行中（未招募）1 期
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 人开始时间: 2021年6月17日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 340
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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,
- •Total bilirubin <1.5 time the upper limit of normal (ULN) (< 3 time the upper limit of normal for Gilbert’s disease),
- •Serum ALT and AST < 1.5 x ULN for age,
- •Creatinine clearance > 45ml / min using the Cockcroft and Gault formula,
- •International Normalized Ratio (INR) or Prothrombin Time (PT) must be within the normal ranges as per institution's standard. A window of 5% is allowed.
- •Patients receiving prophylactic/short-term low molecular weight heparin are allowed to participate as long as the PT/INR values are within the expected target range of their current dose.
- •Clinically normal cardiac function based on -left ventricular ejection fraction (= 50%) as assessed either by multi-gated acquisition scan or cardiac ultrasound and 12 lead ECG without clinically relevant abnormalities.
- •Patients = 18 years old and must be able to give written informed consent.
- •Women of child-bearing potential must have a negative pregnancy test.
- •Patients of childbearing / reproductive potential must agree to use highly effective methods of contraception based on the Clinical Trial Facilitation Group (CTFG) guidance as of registration and up to 6 months after the last treatment dose.
- •Female subjects who are breast feeding should agree to discontinue nursing prior to the first dose of study treatment and up to 6 months after the last study treatment.
- •Before patient registration/randomization, written informed consent must be given according to ICH/GCP, and national/local regulations.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 250
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 90
排除标准
- •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.
- •Cerebrovascular accident including transient ischemic attack and thromboembolic event like symptomatic pulmonary embolism.
- •Nasopharynx and sino-nasal tumor.
- •Surgery or investigational drugs or chemotherapy or other anticancer therapy within 4w before registration. Curative radiation therapy (60-70 Gy) within 8w of registration. Palliative radiation therapy will be allowed.
- •Known untreated and uncontrolled brain metastases or carcinomatous meningitis.
- •Known diagnosis of immune deficiency or a known history of HIV (HIV 1/2 antibodies).
- •Known active Hepatitis B or Hepatitis C or pre-existing liver cirrhosis.
- •Known pre-existing ILD.
- •Other uncontrolled active illnesses.
- •Any psychiatric, psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
- •Any malignancy (other than SCCHN, non-melanoma skin cancer or localized cervical cancer or localized and presumed cured prostatic cancer or basal cell carcinoma of the skin and carcinoma in situ of the cervix or bladder) within the last 3 years prior to registration.
研究者
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