JPRN-UMIN000010817已完成1 期
The valproic acid combination chemotherapy for advanced squamous cell carcinoma of the esophagus phase 1/2 clinical trial - The valproic acid combination chemotherapy for advanced squamous cell carcinoma of the esophagus phase 1/2 clinical trial
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 86
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20years-old 至 75years-old(—)
- 性别
- All
入选标准
- 未提供
排除标准
- •1) Those who has cancers concurrency or has a metachronous cancers with disease-free interval less than 5 years (carcinoma in situ lesions and carcinoma in situ that are considered cured by local treatment is not included) 2) Patients with esophageal primary tumor forming a fistula. 3) Patients undergone chemotherapy as the prior treatment. FP therapy until 2 course as the adjuvant chemotherapy is not included. 4) Patients undergone chemotherapy within 6 months of the date of registration. 5) Patients suffering from infection requiring systemic treatment. 6) Patients admitted fever over 38 degree. 7) Women with (making) the possibility of pregnancy and pregnant or lactating women. 8) Patients with mental disorders are thought to require treatment or during treatment with antipsychotic drugs. 9) The oral or injectable steroids are under use. 10) Patients with the uncontrolled diabetes. 11) Patients with the uncontrolled hypertension. 12) Patients with the unstable angina or myocardial infarction within 6 months. 13) Patients who have a history of viral hepatitis with HBs antibody or HCV antibody-positive. 14) Patients with HIV antibody-posotive. 15) Patients with the chronic lung disease (interstitial pneumonia, pulmonary fibrosis, advanced emphysema). 16) Cases the physician (sharing) was deemed inappropriate as the subject of the study investigator.
研究者
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不适用
Preclinical and clinical study of valproic acid plus cisplatin and cetuximab in recurrent and/or metastatic squamous cell carcinoma of head and neckRecurrent and/or metastatic squamous cell carcinoma of head and neckMedDRA version: 17.0Level: PTClassification code 10067821Term: Head and neck cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2014-001523-69-ITIstituto Nazionale Tumori di Napoli - Fondazione G. Pascale39
