Hepatic Artery Infusion Chemotherapy Plus Recombinant Human Type-5 Adenovirus vs Hepatic Artery Infusion Chemotherapy Alone for Unresectable Hepatocellular Carcinoma at Barcelona Clinic Liver Cancer A-B Stage
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 304
- 试验地点
- 1
- 主要终点
- Overall survival (OS)
研究概览
简要总结
Hepatic artery infusion chemotherapy (HAIC) is effective and safe for hepatocellular carcinoma (HCC). Recombinant Human Type-5 Adenovirus (H101) is safe for HCC. The purpose of this study is to evaluate the efficacy and safety of HAIC combined with H101 compared with HAIC alone in patients with unresectable hepatocellular carcinoma (HCC) at barcelona clinic liver cancer A-B stage.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •The diagnosis of HCC
- •Patients must have at least one tumor lesion that can be accurately measured according to mRECIST criteria.
- •With no previous treatment
- •Single lesion with tumor size larger 7cm or multiple lesions
- •No Cirrhosis or cirrhotic status of Child-Pugh class A only
- •Not amendable to surgical resection ,local ablative therapy and any other cured treatment.
- •BCLC A-B stage
- •The following laboratory parameters:
- •Platelet count ≥ 50,000/μL Hemoglobin ≥ 8.5 g/dL Total bilirubin ≤ 30mmol/L Serum albumin ≥ 32 g/L ASL and AST ≤ 6 x upper limit of normal Serum creatinine ≤ 1.5 x upper limit of normal INR ≤ 1.5 or PT/APTT within normal limits Absolute neutrophil count (ANC) >1,500/mm3
排除标准
- •Patients complicated by history of heart disease, history of gastrointestinal bleeding within 1 month, severe infection (> grade 2 National Cancer Institute [NCI] -common Terminology Criteria for Adverse Events [CTCAE] version 4.0) or other serious associated diseases will not be able to tolerate treatment
- •With other malignant tumors
- •Known or suspected allergy to the investigational agents or any agent given in association with this trial
- •History of organ allograft
- •Pregnant or lactating woman
- •patients with poor compliance
研究组 & 干预措施
HAIC plus H101
Patients receive oxaliplatin, 5-fluorouracil and leucovorin and recombinant human type-5 adenovirus 0.5ml via hepatic artery
干预措施: HAIC of FOLFOX (Procedure)
HAIC plus H101
Patients receive oxaliplatin, 5-fluorouracil and leucovorin and recombinant human type-5 adenovirus 0.5ml via hepatic artery
干预措施: H101 (Drug)
HAIC
Patients receive oxaliplatin, 5-fluorouracil and leucovorin and normal saline via hepatic artery
干预措施: HAIC of FOLFOX (Procedure)
HAIC
Patients receive oxaliplatin, 5-fluorouracil and leucovorin and normal saline via hepatic artery
干预措施: Placebos (Drug)
结局指标
主要结局
Overall survival (OS)
时间窗: 24 months
OS was defined as the duration from the date of randomization until the date of death from any cause. Participants who were lost to follow-up were censored at the last date the participant was known to be alive, and participants who remained alive were censored at the time of data cutoff.
次要结局
- Progression free survival (PFS)(24 months)
- Number of adverse events(30 days)
- Conversion rate to resection(24 months)
研究者
Shi Ming
Proffessor
Sun Yat-sen University