NCT07052253招募中2 期
An Open-label, Multicenter, Phase II Clinical Study of AK104/AK112 in Combination With TT-00420 Tablet in Patients With Advanced Hepatocellular Carcinoma.
Akeso1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年7月18日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
An Open-label, Multicenter, Phase II Clinical Study of AK104/AK112 in Combination with TT-00420 Tablet in Patients with Advanced Hepatocellular Carcinoma(HCC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Age ≥ 18 and ≤ 75 years.
- •Histologically or cytologically confirmed hepatocellular carcinoma, or meets the clinical diagnostic criteria for hepatocellular carcinoma.
- •Barcelona Clinic Liver Cancer (BCLC) stage C; or stage B and assessed by the investigator as unsuitable for curative topical treatment.
- •For cohorts A and B: No prior systemic anti-cancer treatment for hepatocellular carcinoma.
- •At least one measurable lesion according to RECIST v1.1 criteria.
- •Child-Pugh liver function score ≤
- •ECOG performance status of 0 or
- •Clinically controllable HBV or HCV infection.
- •Adequate organ and bone marrow function.
排除标准
- •Previous histologically or cytologically confirmed fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma, etc.
- •Diagnosed with another malignancy within 3 years.
- •History of hepatic encephalopathy.
- •Presence of clinically significant pericardial effusion; symptomatic pleural effusion requiring drainage or moderate to severe ascites uncontrolled by diuretics.
- •Concurrent infection with HBV and HCV.
- •Presence of central nervous system metastases or meningeal metastases.
- •Esophageal or gastric variceal bleeding within 6 months. Imaging (CT or MRI) shows extrahepatic metastasis invading major blood vessels or indistinct vascular boundaries, with high bleeding risk assessed by the researcher.
- •Liver tumor volume exceeding 50% of total liver volume; portal vein main trunk tumor thrombus or tumor thrombus in contralateral main branch of the portal vein, or mesenteric vein tumor thrombus; presence of inferior vena cava thrombus or involvement of the heart.
- •Received topical treatment for liver cancer, any systemic anti-tumor drugs, or other clinical trial drugs within 4 weeks prior to the first administration.
- •Unable to swallow, or has severe gastrointestinal disease or gastrointestinal dysfunction. History of intestinal obstruction or intestinal perforation within 6 months.
- •Uncontrolled hypertension, symptomatic heart failure, symptomatic or poorly controlled arrhythmia, myocarditis, cardiomyopathy, history of malignant arrhythmias.
- •Participants with severe bleeding tendencies or coagulation disorders.
- •Active pulmonary tuberculosis, active syphilis, or history of HIV infection.
- •Severe infection within 4 weeks prior to the first administration, or received systemic anti-infective treatment within 14 days.
- •Other conditions with high medical risk or secondary tumor symptoms, which, in the judgment of the researcher, make the participant unsuitable for participation in the study.
研究组 & 干预措施
Cohort 2（Safety Lead-In Phase）
Experimental
AK112 20mg/kg Q3W + TT-00420 10mg PO QD（n=3-6）
干预措施: TT-00420 (tinengotinib) (Drug)
Cohort 1（Safety Lead-In Phase）
Experimental
AK104 10mg/kg Q3W+TT-00420 10mg PO QD （n=3-6）
干预措施: TT-00420 (tinengotinib) (Drug)
Cohort 1（Safety Lead-In Phase）
Experimental
AK104 10mg/kg Q3W+TT-00420 10mg PO QD （n=3-6）
干预措施: AK104 (Drug)
Cohort 2（Safety Lead-In Phase）
Experimental
AK112 20mg/kg Q3W + TT-00420 10mg PO QD（n=3-6）
干预措施: AK112 (Drug)
Cohort A（Expansion Cohort Phase）
Experimental
AK104 10mg/kg Q3W + TT-00420 10mg PO QD（n=20-30）
干预措施: TT-00420 (tinengotinib) (Drug)
Cohort A（Expansion Cohort Phase）
Experimental
AK104 10mg/kg Q3W + TT-00420 10mg PO QD（n=20-30）
干预措施: AK104 (Drug)
Cohort B（Expansion Cohort Phase）
Experimental
AK112 20mg/kg Q3W + TT-00420 10mg PO QD（n=20-30）
干预措施: TT-00420 (tinengotinib) (Drug)
Cohort B（Expansion Cohort Phase）
Experimental
AK112 20mg/kg Q3W + TT-00420 10mg PO QD（n=20-30）
干预措施: AK112 (Drug)
Cohort C（Expansion Cohort Phase）
Experimental
TT-00420 10mg PO QD（n=20-30）
干预措施: TT-00420 (tinengotinib) (Drug)
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: Up to 2 years
assessed by investigator per RECIST v1.1
次要结局
- Progression-free survival (PFS)(up to 2 years)
- Disease control rate(DCR)(Up to 2 years)
- Duration of Response (DOR)(Up to 2 years)
- Time to Response (TTR)(Up to 2 years)
- Time to Progression (TTP)(Up to 2 years)
- Overall Survival(OS)(Up to 2 years)
研究者
研究点 (1)
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