Using AK104 to prevent recurrence of liver cancer after surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.