Hepatocellular Carcinoma
Conditions
Brief summary
The efficacy and safety of AK104 as adjuvant therapy in hepatocellular carcinoma of high recurrence risk after curative resection.
Interventions
BIOLOGICALAK104
Subjects will receive AK104 until disease progression or for a maximum of 16 cycles
BIOLOGICALplacebo
Subjects will receive placebo until disease progression or for a maximum of 16 cycles
Sponsors
Akeso
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence free survival (RFS) by BICR | Up to 48 months | The time comfirmed by BICR from randomization to recurrence or death. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 12-months recurrence free survival (RFS-12) | 12 months | The proportion of patients without recurrence or death at 12 month. |
| 24-months recurrence free survival (RFS-24) | 24 months | The proportion of patients without recurrence or death at 24 month. |
| Time to recurrence (TTR) | Up to 48 months | The time from randomization to recurrence. |
| Overall survival (OS) | Up to 48 months | The time from randomization to death for any reason. |
| Types and proportions of adverse events (AEs) | Up to 48 months | — |
Countries
China
Contacts
Primary ContactTing Liu, M.D.
Outcome results
None listed