NCT05363722Unknown1 期
A Randomized, Open-label, Multicenter Phase Ib Clinical Study to Observe the Effectiveness and Safety of Different Doses of IBI310,Bevacizumab Combined With Sintilimab in the First-line Treatment of Advanced Hepatocellular Carcinoma
Shanghai Zhongshan Hospital0 个研究点目标入组 80 人开始时间: 2022年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 80
- 主要终点
- Objective response rate (ORR)
研究概览
简要总结
This is a randomized, open-label, multicenter Phase Ib study to evaluate the effectiveness and safety of different doses of IBI310, bevacizumab combined with sintilimab in patients with locally advanced or metastatic HCC who have not previously received systemic therapy, are unsuitable for radical surgical resection or local treatment, or have progressive disease after surgical resection or local treatment.
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
- 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
- •Histologically/cytologically confirmed hepatocellular carcinoma, or meeting the clinical diagnostic criteria for hepatocellular carcinoma ;
- •Aged ≥18 years,≤75 years;
- •ECOG performance status score of 0 or 1 point;
- •Barcelona Clinic Liver Cancer (BCLC) stage C, or Stage B not suitable for radical surgery and/or local treatment;
- •No systemic antitumor treatment for hepatocellular carcinoma before the first administration;
- •At least 1 measurable lesion according to the Response Evaluation Criteria in Solid Tumors Version 1.1(RECIST V1.1), or measurable lesion with definite progression after local treatment (based on RECIST V1.1 criteria);
- •Child-Pugh Class A or B(≤7);
- •Adequate organ and bone marrow function.
- •Expected life time is over 12 weeks.
- •Take effective contraceptive measures
- •Willing to attend the study and having given the ICF
排除标准
- •Known fibrolamellar HCC, sarcomatoid HCC, mixed cholangiocarcinoma and HCC
- •History of hepatic encephalopathy or liver transplantation
- •Pleural, ascites, and pericardial effusion with clinical symptoms requiring drainage
- •HBV-DNA>2000 IU/ML or 10^4 copies/ml；Untreated positive HCV-RNA；HbsAg and anti-HCV antibody were both positive
- •History of GI bleeding within 6 months, or severe (G3) varices at endoscopy within 3 months
- •Arteriovenous embolism within 6 months
- •The tumor thrombus involved both main and branch portal veins, main portal veins and mesenteric veins or inferior vena cava.
- •Antiplatelet drugs were administered for 10 days for therapeutic purposes 2 weeks before administration
- •Uncontrolled hypertension
- •Unrecovered AE（>CTCAE grade 1） due to previous treatment
- •Heart failure (NYHA Classification III-IV), or poorly controlled arrhythmias
- •History of gastrointestinal perforation, fistula, intestinal obstruction, extensive bowel resection, Crohn's disease, ulcerative colitis, or chronic diarrhea
- •With lung fibrosis, interstitial lung disease, pneumoconiosis, drug-associated pneumonia and serious impairment in lung function
- •Active tuberculosis
- •Infected with HIV or syphilis
- •Severe infections that are active or clinically poorly controlled
- •Use of immunosuppressive drugs within 4 weeks prior to initial dosing
- •Receipt of live attenuated vaccine within 4 weeks prior to randomization
- •Significant traumatic injury or major surgical procedure within 28 days prior to randomization
- •Other conditions that the investigator judged inappropriate for inclusion
- •Prior immunotherapy or targeted therapy
- •Treatment of Traditional Chinese medicine with anti-tumor indications or drugs with immunomodulatory effects whitin 2 weeks
- •Pregnant or breast-feeding women
研究组 & 干预措施
Arm A（IBI310 0.5mg/kg）
Experimental
IBI310 0.5mg/kg IV d1 Q6W, sintilimab 200mg IV d1 Q3W, combined with bevacizumab 15mg/kg IV d1，Q3W
干预措施: sintilimab (Drug)
Arm A（IBI310 0.5mg/kg）
Experimental
IBI310 0.5mg/kg IV d1 Q6W, sintilimab 200mg IV d1 Q3W, combined with bevacizumab 15mg/kg IV d1，Q3W
干预措施: bevacizumab (Drug)
Arm A（IBI310 0.5mg/kg）
Experimental
IBI310 0.5mg/kg IV d1 Q6W, sintilimab 200mg IV d1 Q3W, combined with bevacizumab 15mg/kg IV d1，Q3W
干预措施: IBI310（0.5mg/kg） (Drug)
Arm B（IBI310 0.3mg/kg）
Experimental
IBI310 0.3mg/kg IV d1 Q6W, sintilimab 200mg IV d1 Q3W, combined with bevacizumab 15mg/kg IV d1，Q3W
干预措施: IBI310（0.3mg/kg） (Drug)
Arm B（IBI310 0.3mg/kg）
Experimental
IBI310 0.3mg/kg IV d1 Q6W, sintilimab 200mg IV d1 Q3W, combined with bevacizumab 15mg/kg IV d1，Q3W
干预措施: sintilimab (Drug)
Arm B（IBI310 0.3mg/kg）
Experimental
IBI310 0.3mg/kg IV d1 Q6W, sintilimab 200mg IV d1 Q3W, combined with bevacizumab 15mg/kg IV d1，Q3W
干预措施: bevacizumab (Drug)
结局指标
主要结局
Objective response rate (ORR)
时间窗: The proportion of patients with complete response or partial response, through study completion, an average of 3 years
efficacy
次要结局
- Time to Progression（TTP）according to RECIST V1.1 criteria(From date of randomization until the date of first documented progression, up to 48 months)
- Time to Progression（TTP）according to mRECIST criteria(From date of randomization until the date of first documented progression, up to 48 months)
- Progresison Free Surviva（PFS）according to RECIST V1.1 criteria(From date of randomization until the date of the first documented progression or date of death from any cause, whichever comes first, up to 48 months)
- Progresison Free Surviva（PFS）according to mRECIST criteria(From date of randomization until the date of the first documented progression or date of death from any cause, whichever comes first, up to 48 months)
- Overall survival (OS)(From date of randomization until death from any cause，through study completion, an average of 3 years)
- Immune Best Overall Response（iBOR）according to iRECIST criteria(The best timepoint response recorded from the start of the study treatment until the end of treatment, taking into account any requirement for confirmation, through study completion, an average of 3 years)
- Duration of Response（DOR）according to RECIST V1.1 criteria(From date of randomization until the date of first documented progression, up to 48 months)
- Duration of Response（DOR）according to mRECIST criteria(From date of randomization until the date of first documented progression, up to 48 months)
- Disease Control Rate（DCR） according to RECIST V1.1 criteria(The percentage of patients whose therapeutic intervention has led to a complete response, partial response, or stable disease, through study completion, an average of 3 years)
- Disease Control Rate（DCR） according to mRECIST criteria(The percentage of patients whose therapeutic intervention has led to a complete response, partial response, or stable disease, through study completion, an average of 3 years)
研究者
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