A Phase II Clinical Study of AK104/AK112 in Combination With TT-00420 Tablet for Advanced HCC.
- Conditions
- Hepatocellular Carcinoma (HCC)
- Interventions
- Registration Number
- NCT07052253
- Lead Sponsor
- Akeso
- Brief Summary
An Open-label, Multicenter, Phase II Clinical Study of AK104/AK112 in Combination with TT-00420 Tablet in Patients with Advanced Hepatocellular Carcinoma(HCC).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 100
- 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 ≤7. ECOG performance status of 0 or 1.
- Clinically controllable HBV or HCV infection.
- Adequate organ and bone marrow function.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 1(Safety Lead-In Phase) TT-00420 (tinengotinib) AK104 10mg/kg Q3W+TT-00420 10mg PO QD (n=3-6) Cohort 1(Safety Lead-In Phase) AK104 AK104 10mg/kg Q3W+TT-00420 10mg PO QD (n=3-6) Cohort 2(Safety Lead-In Phase) TT-00420 (tinengotinib) AK112 20mg/kg Q3W + TT-00420 10mg PO QD(n=3-6) Cohort 2(Safety Lead-In Phase) AK112 AK112 20mg/kg Q3W + TT-00420 10mg PO QD(n=3-6) Cohort A(Expansion Cohort Phase) TT-00420 (tinengotinib) AK104 10mg/kg Q3W + TT-00420 10mg PO QD(n=20-30) Cohort A(Expansion Cohort Phase) AK104 AK104 10mg/kg Q3W + TT-00420 10mg PO QD(n=20-30) Cohort B(Expansion Cohort Phase) TT-00420 (tinengotinib) AK112 20mg/kg Q3W + TT-00420 10mg PO QD(n=20-30) Cohort B(Expansion Cohort Phase) AK112 AK112 20mg/kg Q3W + TT-00420 10mg PO QD(n=20-30) Cohort C(Expansion Cohort Phase) TT-00420 (tinengotinib) TT-00420 10mg PO QD(n=20-30)
- Primary Outcome Measures
Name Time Method Objective Response Rate (ORR) Up to 2 years assessed by investigator per RECIST v1.1
- Secondary Outcome Measures
Name Time Method Progression-free survival (PFS) up to 2 years assessed by investigator per RECIST v1.1
Disease control rate(DCR) Up to 2 years assessed by investigator per RECIST v1.1
Duration of Response (DOR) Up to 2 years assessed by investigator per RECIST v1.1
Time to Response (TTR) Up to 2 years assessed by investigator per RECIST v1.1
Time to Progression (TTP) Up to 2 years assessed by investigator per RECIST v1.1
Overall Survival(OS) Up to 2 years OS is defined as the time from randomization or first dosing to death due to any cause.
Related Research Topics
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Trial Locations
- Locations (1)
Union Hospital Tongji Medical College Huazhong University of Science And Technology
🇨🇳Wuhan, China
Union Hospital Tongji Medical College Huazhong University of Science And Technology🇨🇳Wuhan, ChinaXiaoping Chen, M.D.Principal Investigator