NCT06586593招募中不适用
ETUDE NEOMEL: TRAITEMENT NEOADJUVANT PAR IMMUNOTHERAPIE DU MELANOME METASTATIQUE OPERABLE EN VIE REELLE (GCC)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 77
- 试验地点
- 9
- 主要终点
- Complete histological response
研究概览
简要总结
This study aims to evaluate efficacy and tolerance of real life neoadjuvant immunotherapy in advanced yet operable melanoma.
The complete histological response will be assessed.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with operable metastatic melanoma (stage III or IV of American Joint Committee on Cancer [AJCC] Stages CLassification) treated with neoadjuvant immunotherapy (anti-PD1 or anti-PD1 + anti-CTLA-4), even if surgery cancelled due to disease progression or complete response or patient's refusal to be operated.
- •Efficacy of the neoadjuvant immunotherapy histologically of radiologically assessed
排除标准
- •Uveal melanoma
结局指标
主要结局
Complete histological response
时间窗: Day 1
Histological response rate on histological analysis of the resected specimen
次要结局
- Objectival response rate(Day 1)
- Event-free survival(Month 12)
- Disease Free Survival after surgery(Month 12)
- Overall survival(Month 18)
- Metastases-free survival(Month 18)
- Frequency of toxicities(Month 12)
- Severity of toxicities(Month 12)
研究者
研究点 (9)
Loading locations...
相似试验
招募中
不适用
Real-world Clinical Outcomes of NSCLC Patients Receiving Neoadjuvant ImmunotherapyNSCLCNCT06317558Cancer Institute and Hospital, Chinese Academy of Medical Sciences4,000
招募中
不适用
The Real World Study of Neoadjuvant Immunotherapy in Early Stage NSCLC in ChinaImmunotherapyLung CancerNCT04286841Guangdong Association of Clinical Trials100
进行中（未招募）
不适用
a Neo-adjuvant Chemotherapy Immunotherapy in Resectable ESCC StudyThe Neoadjuvant Treatment for Resectable Esophageal Squamous Cell CarcinomaNCT06472635Zhejiang University95
撤回
2 期
Neoadjuvant Nivolumab+Ipilimumab Followed by Adjuvant Nivolumab or Neoadjuvant Nivolumab+Ipilimumab Followed by Adjuvant Observation Compared With Adjuvant Nivolumab in Treatment-Naive High-risk Melanoma ParticipantsMelanomaNCT04495010Bristol-Myers Squibb
尚未招募
2 期
Neoadjuvant Immunotherapy in Locally Advanced Colon CancersImmunotherapyColon CancerNCT05833672fan li100