NCT04961138Unknown不适用
Pre-operative Neoadjuvant Therapy Combined With Surgery for Treating Stage III Hepatocellular Carcinoma: an Open, Random, Multicenter, Prospective Study
Second Affiliated Hospital, School of Medicine, Zhejiang University0 个研究点目标入组 164 人开始时间: 2021年8月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 164
- 主要终点
- 1-year disease free survival
研究概览
简要总结
The purpose of present study is to evaluate whether per-operative neoadjuvant therapy combined with surgery could improve the 1-year disease-free survival of stage III hepatocellular carcinoma patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-80 years old, both gender
- •Confirmed diagnosis of stage III hepatocellular carcinoma(HCC)
- •Fulfill the criteria of surgery
- •No other severe comorbidity
- •Eastern Cooperative Oncology Group score(ECOG) 0-2
- •Expected survival > 3months
- •Informed consent obtained.
排除标准
- •Received chemoradiotherapy or other antineoplastic drugs
- •Severe cirrhosis with Child-Pugh score >10
- •Total bilirubin > 1.5 times upper limit, AST or ALT > 2times upper limit, indocyanine green retention rate after 15 min(ICG15) >=40%;
- •Not fulfill the surgery criteria
- •Received major surgery within 1month
- •History of other tumor
- •Participate other clinical trial within 1month
- •Drug or alcohol abuse, AIDS
- •Uncontrollable epileptic seizure or cognitive disorder
- •Severe allergy
- •Other unsuitable conditions.
结局指标
主要结局
1-year disease free survival
时间窗: 1 year
次要结局
- 1-year overall survival(1 year)
- objective response rate(up to 2 months)
- Rate of R0 resection(1 week)
研究者
相似试验
Unknown
2 期
Neoadjuvant Chemotherapy Followed by Preoperative Chemoradiation in Resectable Squamous-cell Esophageal CancerEsophageal NeoplasmsConcurrent ChemoradiotherapySquamous Cell CarcinomaNCT03579004Mona Frolova48
招募中
2 期
Neoadjuvant and Adjuvant Anti-PD1 or Combinations for Locoregionally Advanced MelanomaMelanoma Stage IIIMelanoma Stage IVAdvanced MelanomaMelanomaNCT06295159H. Lee Moffitt Cancer Center and Research Institute90
Unknown
不适用
Neoadjuvant Therapy Combined With Radical Surgery for the Treatment of Small Cell Lung Cancer (SCLC) in II and IIIA StageSmall-cell Lung CancerNCT03523234Peng Zhang300
终止
3 期
Randomized Study on Neoadjuvant Radio-Chemotherapy in Rectal Carcinoma Dukes B and CRectal Cancer Dukes B, Dukes CNCT00309517Austrian Breast & Colorectal Cancer Study Group700
招募中
不适用
Neoadjuvant Chemoimmunotherapy Followed by Surgery and Postoperative RadioimmunotherapyEsophageal Squamous Cell CarcinomaNCT06602843Anhui Provincial Hospital70