NCT05320692进行中（未招募）3 期
A Phase III, Randomized, Open-Label, Multi-center Study of TACE Combined With Camrelizumab Plus Rivoceranib (Apatinib) or TACE Alone in Patients With Incurable Hepatocellular Carcinoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 423
- 试验地点
- 1
- 主要终点
- PFS assessed by BIRC
研究概览
简要总结
A study to evaluate efficacy and safety of transarterial chemoembolization (TACE) in combination with Camrelizumab and Rivoceranib (Apatinib) therapy in patients with incurable hepatocellular carcinoma.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntarily participate in this study and sign informed consent.
- •Subjects diagnosed with HCC or clinically diagnosed with HCC by histopathology / cytology.
- •Baseline imaging examination has at least one measurable lesion.
- •Child-Pugh liver function rating was Grade A Within 7 days before randomization.
- •ECOG PS score within 7 days before randomization: 0 or
- •Other protocol defined inclusion criteria could apply.
排除标准
- •Known hepatocholangiocarcinoma, sarcomatoid hepatocellular carcinoma, mixed cell carcinoma and lamellar cell carcinoma.
- •Subjects who are ready for or have previously received organ or allogeneic bone marrow transplantation.
- •Has any active autoimmune disease or a history of autoimmune disease and may relapse.
- •Suffering from hypertension and can not be well controlled by antihypertensive drugs.
- •With clinical symptoms or diseases of the heart that are not well controlled.
- •Previous or current central nervous system metastasis.
- •The subject has congenital or acquired immune deficiency (such as HIV infection).
- •Thrombotic or embolic events occurred within 6 months prior to the start of study treatment.
- •A history of gastrointestinal hemorrhage or a clear tendency to gastrointestinal bleeding within 6 months prior to the start of study treatment.
- •Abdominal fistula, gastrointestinal perforation or abdominal abscess occurred within 6 months prior to the start of study treatment.
- •Severe, unhealed or cracked wounds and active ulcers or untreated fractures.
- •Known genetic or acquired bleeding or thrombotic tendencies.
- •Severe infection occurred within 4 weeks prior to the start of study treatment.
- •Received live attenuated vaccine treatment within 28 days prior to the start of study treatment.
- •Other investigational drugs were received within 28 days prior to the start of study treatment.
- •According to the assessment of investigator, the subject has other factors that may interfere with the results of the study or cause the forced termination of the study. Other protocol defined exclusion criteria could apply.
研究组 & 干预措施
Treatment group
Experimental
TACE Combined With Camrelizumab Plus Rivoceranib (Apatinib).
干预措施: TACE+Camrelizumab+Apatinib mesylate (Drug)
Control group
Active Comparator
TACE Alone.
干预措施: TACE (Procedure)
结局指标
主要结局
PFS assessed by BIRC
时间窗: approximately 5 years
PFS is defined as the time from the date of randomization until the date of first objective disease progression or death (whichever occurs first).
次要结局
- DCR(approximately 5 years)
- DoR(approximately 5 years)
- The incidence and severity of adverse events (AEs) and serious adverse events (SAEs) as assessed by CTCAE v5.0(approximately 5 years)
- OS(approximately 5 years)
- ORR(approximately 5 years)
研究者
研究点 (1)
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