Efficacy and Safety of Modified Hepatic Artery Infusion Chemotherapy (TOMOX-HAIC) in Combination With Sintilimab and Bevacizumab Biosimilar for the First-line Treatment of Advanced Hepatocellular Carcinoma: a Prospective, Single-arm, Phase II Clinical Study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- objective response rate (ORR)
研究概览
简要总结
This is a single-center, single-arm, phase II clinical study, to explore the efficacy and safety of modified TOMOX-HAIC combined with sintilimab and bevacizumab biosimilar as first line treatment in patients with advanced hepatocellular carcinoma.
详细描述
Hepatocellular carcinoma (HCC) is one of the most common malignant tumors worldwide.The IMbrave150 study and the Orient-32 study demonstrated that PD-1 in combination with bevacizumab confers better survival outcomes in advanced hepatocellular carcinoma. In addition, HAIC combined with targeted therapy and immunotherapy has shown good safety and encouraging efficacy. Oxaliplatin-based FOLFOX regimen is currently the mainstream HAIC chemotherapy regimen (FOLFOX HAIC) in China.
The results of the previous study confirmed that raltitrexed shows promising antitumor activity and safety in hepatocellular carcinoma. Also, TOMOX-HAIC regimen can significantly shorten the infusion duration and is expected to improve the patient experience, quality of life, and adherence while ensuring the efficacy.
In this clinical trial, patients will receive TOMOX-HAIC combined with Sintilimab and bevacizumab biosimilar. The primary endpoint is overall response rate. The secondary endpoint are disease control rate, time to progression, duration of response, overall survival, and safety
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be willing and able to provide written informed consent/assent for the trial.
- •Males or unpregnant females who age ≥ 18 years, ≤75 years.
- •The investigator believes the patient is capable of complying with the study protocol.
- •Histologically, cytologically or clinically confirmed advanced hepatocellular carcinoma.
- •is not a candidate for radical surgery
- •not received previous systemic treatment
- •patients must have at least one measurable lesion (RECIST 1.1)
- •ECOG PS：0-1, 14 days before enrollment
- •Child-Pugh A or Child-Pugh B ≤ 7, 14 days before enrollment
排除标准
- •Prior history of other malignant tumors
- •Current or prior immunodeficiency disorders or autoimmune diseases
- •Subjects have untreated or incompletely treated esophageal and/or gastric varices with bleeding or high risk of bleeding
- •Subjects who are not available for follow-up or are participating in other clinical trials that have the potential to interfere with this study
- •Conditions considered unsuitable for inclusion by researchers
研究组 & 干预措施
Combination therapy
TOMOX-HAIC combined with Sintilimab and bevacizumab biosimilar
干预措施: TOMOX-HAIC (Procedure)
Combination therapy
TOMOX-HAIC combined with Sintilimab and bevacizumab biosimilar
干预措施: Sintilimab (Drug)
Combination therapy
TOMOX-HAIC combined with Sintilimab and bevacizumab biosimilar
干预措施: Bevacizumab (Drug)
结局指标
主要结局
objective response rate (ORR)
时间窗: 24 months
ORR is defined as the percentage of subjects with evidence of a confirmed complete response (CR) or partial response (PR) as per Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1. and mRECIST
次要结局
- disease control rate (DCR)(24 months)
- Progression-Free Survival (PFS)(24 months)
- Time to progression (TTP)(24 months)
- Duration of response (DOR)(24 months)
- overall survival (OS)(24 months)
- adverse event (AE)(24 months)
研究者
Lu Wang, MD, PhD
Director of Hepatobiliary Surgery
Fudan University