CTRI/2024/04/065574尚未招募3 期
A multicentre randomized study of neoadjuvant systemic therapy in oral cavity cancer - NI
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
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 T3 N1/N2/N3 or T4 HNSCC of the oral cavity
- •2. Age: Male or female or transgender subjects aged more than 18 years.
- •3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 to 2.
- •4. Subjects must have normal organ and marrow function as per institute protocols
- •5. 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 absence of active AIDS defining conditions.
- •6. Both men and women of all races and ethnic groups are eligible for this study.
- •7. 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.
- •8. 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 less than 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,Steroid 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 (less 6 months prior to enrollment), myocardial infarction (less 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. Known prior severe hypersensitivity to investigational product or any component in its formulations, including known severe hypersensitivity reactions to monoclonal antibodies (NCI-CTCAE v5.0 Grade 3).
- •7. Pregnant and lactating women are excluded from this study.
研究者
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