🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in China / NCT07052253
Recruiting Phase 2

A Phase II Clinical Study of AK104/AK112 in Combination With TT-00420 Tablet for Advanced HCC.

NCT07052253 · tracked via the Priya Life Science China tracker
Sponsor
Akeso
Phase
Phase 2
Started
2025-07-18
Last updated
2026-03-16

Condition(s) studied

Hepatocellular Carcinoma (HCC)

Investigational drug(s) / intervention(s)

TT-00420 (tinengotinib)AK104AK112

TT-00420 (tinengotinib): oral

AK104: intravenous

AK112: intravenous

Study 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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: 1. Age ≥ 18 and ≤ 75 years. 2. Histologically or cytologically confirmed hepatocellular carcinoma, or meets the clinical diagnostic criteria for hepatocellular carcinoma. 3. Barcelona Clinic Liver Cancer (BCLC) stage C; or stage B and assessed by the investigator as unsuitable for curative topical treatment. 4. For cohorts A and B: No prior systemic anti-cancer treatment for hepatocellular carcinoma. 5. At least one measurable lesion according to RECIST v1.1 criteria. 6. Child-Pugh liver function score ≤7. ECOG performance status of 0 or 1. 7. Clinically controllable HBV or HCV infection. 8. Adequate organ and bone marrow function. Exclusion Criteria: 1. Previous histologically or cytologically confirmed fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma, etc. 2. Diagnosed with another malignancy within 3 years. 3. History of hepatic encephalopathy. 4. Presence of clinically significant pericardial effusion; symptomatic pleural effusion requiring drainage or moderate to severe ascites uncontrolled by diuretics. 5. Concurrent infection with HBV and HCV. 6. Presence of central nervous system metastases or meningeal metastases. 7. 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. 8. 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. 9. Received topical treatment for liver cancer, any systemic anti-tumor drugs, or other clinical trial drugs within 4 weeks prior to the first administration. 10. Unable to swallow, or has severe gastrointestinal disease or gastrointestinal dysfunction. History of intestinal obstruction or intestinal perforation within 6 months. 11. Uncontrolled hypertension, symptomatic heart failure, symptomatic or poorly controlled arrhythmia, myocarditis, cardiomyopathy, history of malignant arrhythmias. 12. Participants with severe bleeding tendencies or coagulation disorders. 13. Active pulmonary tuberculosis, active syphilis, or history of HIV infection. 14. Severe infection within 4 weeks prior to the first administration, or received systemic anti-infective treatment within 14 days. 15. 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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Union Hospital Tongji Medical College Huazhong University of Science And Technology Wuhan China Recruiting

More Akeso trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07052253 on ClinicalTrials.gov ↗ ← All trials in China