CTRI/2022/12/048386招募中3 期
A randomized study of neoadjuvant systemic therapy in oral cavity cancer - TRIDENT
Cancer Research and Statistics Foundation0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
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
入选标准
- •1. Subjects must have T3N2-N3 or T4 HNSCC in the oral cavity.
- •2. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2.
- •3. Subjects must have normal organ and marrow function as per institute protocols.
- •4. Patients with HIV are potentially eligible, as long as they have a CD4 count > 200, are on concurrent HAART (highly active antiretroviral therapy), and have an absence of active AIDS-defining conditions.
- •5. Both men and women of all races and ethnic groups are eligible for this study.
- •6. Willing and able to comply with all study requirements, including treatment, able to be followed up at regular intervals, and/or nature of required assessments.
- •7. Ability to understand and the willingness to sign a written informed consent document.
排除标准
- •1. Subjects who are receiving any other investigational agents.
- •2. Within 2 weeks of administration of a chemotherapeutic agent.
- •3. Current use of immunosuppressive medication, EXCEPT for the following:
- •a. intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection);
- •b. Systemic corticosteroids at physiologic doses = 10 mg/day of prednisone or equivalent;
- •c. Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)
- •d. Steroids for raised intracranial pressure due to the disease itself e, Steroids use for avoidance or treatment of emesis.
- •4. Uncontrolled comorbidities including active autoimmune disease that might deteriorate when receiving a chemotherapeutic agent. Clinically significant (i.e., active)cardiovascular disease: cerebrovascular accident/stroke ( < 6 months prior to enrollment), myocardial infarction ( < 6 months prior to enrollment), unstable angina, congestive heart failure (= New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication. Patients with severe renal and liver dysfunction Child-Pugh B or C
- •5. Prior organ transplantation including allogeneic stem-cell transplantation.
- •6. Active infection requiring systemic therapy.
- •7. Known prior severe hypersensitivity to investigational product or any component in its formulations, including known severe hypersensitivity reactions to monoclonal antibodies (NCI-CTCAE v4.03 Grade = 3).
- •8. Pregnant and lactating women are excluded from this study.
研究者
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