Actively Recruiting
A Phase III Study of AK104 as Adjuvant Therapy in HCC With High Risk of Recurrence After Curative Resection
Led by Akeso · Updated on 2025-03-12
570
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The efficacy and safety of AK104 as adjuvant therapy in hepatocellular carcinoma of high recurrence risk after curative resection.
CONDITIONS
Official Title
A Phase III Study of AK104 as Adjuvant Therapy in HCC With High Risk of Recurrence After Curative Resection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pathological diagnosis of hepatocellular carcinoma without any metastasis
- Underwent radical resection as the only anti-tumor treatment
- No evidence of residual cancer during or after surgery
- Presence of high risk factors for postoperative recurrence
- Child-Pugh grade A liver function
- ECOG performance status score of 0
- Controlled underlying causes of hepatocellular carcinoma
You will not qualify if you...
- Fibrolamellar hepatocellular carcinoma, sarcoma-like hepatocellular carcinoma, cholangiocarcinoma, or similar
- Any anti-tumor treatment other than radical surgery before randomization
- Severe liver function complications indicating precarious liver function
- Recent procedures or medications causing high risk of bleeding
- Poorly controlled or symptomatic hypertension, congestive heart failure, arrhythmia, or similar
- Inability to perform enhanced CT or MRI scans of the liver
- Recent severe infections or recent use of systemic antibiotics
- Active autoimmune diseases
- History of other incurable malignant tumors
- History of transplantation
- Pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
T
Ting Liu, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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