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

Launched by AKESO · Jun 26, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new combination treatment for people with advanced liver cancer, specifically hepatocellular carcinoma (HCC). The study is testing two medicines, AK104/AK112 and TT-00420 tablets, to see how well they work together in treating this type of cancer when it has progressed and can’t be cured with surgery or other local treatments. The trial is currently not recruiting participants but will include adults aged 18 to 75 who have confirmed advanced liver cancer and meet certain health criteria, such as having stable liver function and at least one measurable tumor.

If you join the study, you can expect to receive this combination treatment while being closely monitored by the medical team. The trial is designed for people who have not yet received other systemic treatments (treatments that affect the whole body) for their liver cancer. People with certain health conditions, such as other cancers, serious infections, or severe heart or liver problems, may not be eligible. The goal of the study is to find out if this new treatment can help control the cancer and improve outcomes for patients with advanced liver cancer. Your healthcare team will explain all the details and support you throughout the process if you decide to participate.

Gender

ALL

Eligibility criteria

• 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.