NCT05489289 A Phase III Study of AK104 as Adjuvant Therapy in HCC With High Risk of Recurrence After Curative Resection
| NCT ID | NCT05489289 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Akeso |
| Condition | Hepatocellular Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 570 participants |
| Start Date | 2023-01-05 |
| Primary Completion | 2026-01-28 |
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.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 570 participants in total. It began in 2023-01-05 with a primary completion date of 2026-01-28.
⚠ 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
The efficacy and safety of AK104 as adjuvant therapy in hepatocellular carcinoma of high recurrence risk after curative resection.
Eligibility Criteria
Inclusion Criteria: 1. Pathological diagnosis of HCC without any metastasis; 2. Receiving radical resection as the only anti-tumor treatment; 3. No evidence of residual cancer found during or after the operation; 4. Presence of any high risk factor of postoperative recurrence; 5. Child-Pugh grade: A; 6. ECOG score: 0; 7. Controlled underlying causes of HCC. Exclusion Criteria: 1. Fibrolamellar hepatocellular carcinoma, sarcoma-like hepatocellular carcinoma, cholangiocarcinoma, etc; 2. Any anti-tumor treatment other than radical surgery before randomization; 3. Precarious liver function indicated by severe complications; 4. Recent procedures or medications leading to high risk of bleeding; 5. Poorly controlled or symptomatic hypertension, congestive heart failure, arrhythmia, etc; 6. Failure of performing enhanced CT or MRI scans of the liver; 7. Recent severe infections or systemic antibiotics use; 8. Active autoimmune diseases; 9. History of other incurable malignant tumors; 10. History of transplantation; 11. Pregnancy.
Contact & Investigator
Jia Fan, Ph.D.
PRINCIPAL INVESTIGATOR
Fudan University
Frequently Asked Questions
Who can join the NCT05489289 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Hepatocellular Carcinoma. 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 NCT05489289 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 570 participants.
Is NCT05489289 currently recruiting?
Yes, NCT05489289 is actively recruiting participants. Contact the research team at clinicaltrials@akesobio.com for enrollment information.
Where is the NCT05489289 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT05489289 clinical trial?
NCT05489289 is sponsored by Akeso. The principal investigator is Jia Fan, Ph.D. at Fudan University. The trial plans to enroll 570 participants.
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