AK104: Subjects will receive AK104 until disease progression or for a maximum of 16 cycles
placebo: Subjects will receive placebo until disease progression or for a maximum of 16 cycles
Study summary
The efficacy and safety of AK104 as adjuvant therapy in hepatocellular carcinoma of high recurrence risk after curative resection.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Recurrence free survival (RFS) by BICR — Up to 48 months The time comfirmed by BICR from randomization to recurrence or death.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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