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临床试验/CTRI/2024/02/062655
CTRI/2024/02/062655
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To evaluate effect of immunotherapy on clinical parameters using PET CT Scan in patients diagnosed with metastatic or recurrent unresectable head and neck cancer-a retrospective observational study

HCG NCHRI Cancer Centre1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2024年2月19日最近更新:

概览

阶段
不适用
状态
已完成
发起方
HCG NCHRI Cancer Centre
入组人数
10
试验地点
1
主要终点
to measure overall survival rate, duration of response and progression free survival

概览

简要总结

Head and Neck cancers accounts for the sixth most common cancer worldwide with 8  lakh new cancer cases and 4.5 lakhs deaths worldwide.50-60%patients treated for HNC have a tendency for loco-regional recurrence within 2 years and 20-30% patients develop distant metastasis.

despite the development in chemotherapy targeted radiotherapy and surgery the estimated survival of HNSCC remains approximately 50%.

For second line treatment options for patients refractory to platinum based chemotherapy cetuximab/taxanes/methotrexate has become the standard therapy with recurrent and or metastatic local disease,resulting in progression free survival of only 2-3 months with a response rate of 4-14%.

for patients who develop unresectable or metastatic recurrence systemic therapy depends upon platinum sensitivity as well as biological factord such as PDL1 receptor status .Sytemic therapy includes platinum based chemotherapy combination with or without Immune check point inhibitors.

Tumour cells assume particular characteristics that allow them to evade the immune system by activating co-inhibitory pathways ,thereby inducing immune tolerance and tumour progression

the use of anti-PD-1/PD-L1 has shown to restore T-cell mediated anti-tumour immunity

Pembrolimuzumab and Nivolumabv have been approved for patients with metastatic,recurrent and unresectable HNSCC

We evaluate the OVERALL RESPONSE RATE,DURATION OF RESPONSE AND PROGRESSION FREE SURVIVAL using PET-CT Scan of patients who are undergoing Immunotherapy

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

  • Recurrent and Metastatic head and neck cancer patients who received Immunotherapy from September 2022 to September 2023.

排除标准

  • study does not have exclusion criteria.

结局指标

主要结局

to measure overall survival rate, duration of response and progression free survival

时间窗: After starting immunotherapy, every three weeks

次要结局

  • NOT APPLICABLE(NOT APPLICABLE)

研究者

发起方
HCG NCHRI Cancer Centre
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Nidhi Hari

HCG-NCHRI Cancer Centre

研究点 (1)

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