Low dose Nivolumab plus DCF(Docetaxel, Cisplatin, 5-Flourouracil) in Locally Advanced Technically Unresectable Oral Cavity Cancer – A Single Centre Study From Eastern India.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- To determine Curative Resection Rate with DCF plus low dose nivolumab in locally advanced unresectable oral cavity cancer patients.
研究概览
简要总结
This research proposal aims to evaluate the combination of low-dose Nivolumab with DCF chemotherapy (Docetaxel, Cisplatin, 5-Fluorouracil) for treating locally advanced, technically unresectable oral cavity cancers. The study seeks to determine if this combination improves curative resection rates, response rates, progression-free survival (PFS), overall survival (OS), and evaluates the toxicity profile. Given the high incidence and challenges in treating unresectable oral cancers in India, this study proposes a more accessible treatment alternative through low-dose Nivolumab, with the hope of improving patient outcomes. The study will be conducted at IMS & SUM Hospital in Bhubaneswar, India.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Biopsy-proven locally advanced oral cavity cancer with T4aN3b or T4bN3b Age above 18 years WithanEasternCooperativeOncologyGroupperformancestatusof 0-2 With normal cardiac, renal, hematologic, hepatic, and pulmonary function.
排除标准
- •Lesion of T4a/T4b with high ITF, base of skull and carotid sheath involvement.
- •Pregnant and lactating females.
- •Patients with uncontrolled DM/HTN Patients with autoimmune disease.
- •Patients receiving immunosuppressants.
结局指标
主要结局
To determine Curative Resection Rate with DCF plus low dose nivolumab in locally advanced unresectable oral cavity cancer patients.
时间窗: Every 3 monthly
次要结局
- To assess Response rate with DCF plus low dose nivolumab in locally advanced unresectable oral cavity cancer.(To establish Progression Free Survival (PFS).)
研究者
Dr Akash Amruthrao Bhange
Institute of Medical sciences and SUM Hospital