Using AK104 to prevent recurrence of liver cancer after surgery
A Randomized, Double-blind, Phase III Clinical Study on the Efficacy and Safety of AK104 Versus Placebo as Adjuvant Therapy for Hepatocellular Carcinoma With High Risk of Recurrence After Curative Resection
This study is testing if a new treatment called AK104 can help prevent liver cancer from coming back after surgery in patients who are at high risk.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 570 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Akeso Industry-sponsored |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT05489289 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the efficacy and safety of AK104 as an adjuvant therapy for patients with hepatocellular carcinoma (HCC) who are at high risk of recurrence following curative surgical resection. Participants will receive either AK104 or a placebo to determine the impact on recurrence rates. The study aims to provide insights into how AK104 can improve outcomes for patients who have undergone surgery for HCC. The trial is designed to assess both the effectiveness of the treatment and any associated safety concerns.
Who should consider this trial
Good fit: Ideal candidates are patients with a confirmed diagnosis of HCC who have undergone radical resection and are at high risk for postoperative recurrence.
Not a fit: Patients with other types of liver cancer or those who have had prior anti-tumor treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the risk of liver cancer recurrence in patients after surgery.
How similar studies have performed: Other studies have shown promise with similar adjuvant therapies in cancer treatment, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Shanghai, Shanghai Municipality
- Zhongshan Hospital, Fudan University — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Principal investigator: Jia Fan, Ph.D. — Fudan University
- Study coordinator: Ting Liu, M.D.
- Email: clinicaltrials@akesobio.com
- Phone: (0760)89873999
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.