2022-502840-11-00招募中2 期
A PHASE IB/II, OPEN-LABEL, MULTICENTER, RANDOMIZED PLATFORM STUDY EVALUATING THE EFFICACY AND SAFETY OF NEOADJUVANT IMMUNOTHERAPY COMBINATIONS IN PATIENTS WITH SURGICALLY RESECTABLE HEPATOCEULLULAR CARCINOMA (MORPHEUS-NEO HCC)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 55
- 试验地点
- 15
- 主要终点
- MPR rate
研究概览
简要总结
To evaluate the efficacy of neoadjuvant immunotherapy-based treatment combinations based on the major pathologic response (MPR) rate
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Morpheus-neo Hcc
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Diagnosis of HCC confirmed either histologically or clinically according to American Association for the Study of Liver Diseases (AASLD) criteria for patients with cirrhosis
- •HCC that is amenable to R0 surgical resection with curative intent in the opinion of the surgeons and oncologists or hepatologists involved in the care of the participant
- •Measurable disease (at least one target lesion) according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) as determined by the investigator
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 within 7 days prior to randomization
- •Child-Pugh Class A within 7 days prior to randomization
- •No prior locoregional or systemic treatment for HCC
排除标准
- •Presence of extrahepatic disease or macrovascular invasion
- •Known fibrolamellar HCC, sarcomatoid HCC, mixed cholangiocarcinoma and HCC, or other rare variants of HCC
- •History of hepatic encephalopathy
- •Moderate or severe ascites
- •Untreated or incompletely treated esophageal and/or gastric varices with bleeding or that are at high risk for bleeding
结局指标
主要结局
MPR rate
MPR rate
次要结局
- pCR rate
- RFS
- EFS
- OS
- ORR
- Proportion of participants downstaged to within Milan criteria (for participants beyond criteria at randomization)
- R0 resection rate (proportion of resected participants obtaining an R0 resection)
- Incidence, nature, and severity of adverse events, serious adverse events, and immune-related adverse events [severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0); severity of cytokine release syndrome (CRS) determined according to the American Society for Transplantation and Cellular Therapy (ASTCT) CRS Consensus Grading Scale]
- Proportion of participants with delayed or canceled surgery due to treatment-related adverse events, as well as length of surgical delay, duration of surgery, length of hospital stay, surgical approach, extent of surgery, intraoperative blood loss, and need for intraoperative blood transfusion
- Post-operative surgical complication rates according to the Clavien- Dindo surgical classification
- Post-operative mortality
研究者
Trial Information System - TISL
Scientific
F. Hoffmann-La Roche AG
研究点 (15)
Loading locations...
相似试验
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
Unknown
2 期
Neoadjuvant Immunotherapy With Chemotherapy for Stage I-IIIB Non-Small Cell Lung Cancer PatientsNon-small Cell Lung CancerNCT04941417Peking Union Medical College60
招募中
3 期
A Trial of SHR-1316/Placebo in Combination With Chemotherapy in Patients With Resectable NSCLCNon-Small-Cell Lung CancerNCT04316364Jiangsu HengRui Medicine Co., Ltd.537
招募中
2 期
A Study of Neoadjuvant Therapy for the Treatment of Patients With Locally Advanced Esophageal Squamous Cell CarcinomaNeoadjuvant TherapyEsophageal Squamous Cell CarcinomaNCT06354530Army Medical Center of PLA266
尚未招募
2 期
Neoadjuvant Immunotherapy in Locally Advanced Colon CancersImmunotherapyColon CancerNCT05833672fan li100