NCT07052253 A Phase II Clinical Study of AK104/AK112 in Combination With TT-00420 Tablet for Advanced HCC.
| NCT ID | NCT07052253 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Akeso |
| Condition | Hepatocellular Carcinoma (HCC) |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-07-18 |
| Primary Completion | 2027-05-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 100 participants in total. It began in 2025-07-18 with a primary completion date of 2027-05-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07052253 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Hepatocellular Carcinoma (HCC). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07052253 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07052253 currently recruiting?
Yes, NCT07052253 is actively recruiting participants. Contact the research team at clinicaltrials@akesobio.com for enrollment information.
Where is the NCT07052253 trial being conducted?
This trial is being conducted at Wuhan, China.
Who is sponsoring the NCT07052253 clinical trial?
NCT07052253 is sponsored by Akeso. The trial plans to enroll 100 participants.
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