A Phase III Study of AK104 as Adjuvant Therapy in HCC With High Risk of Recurrence After Curative Resection

Summary

The efficacy and safety of AK104 as adjuvant therapy in hepatocellular carcinoma of high recurrence risk after curative resection.

Eligibility

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.

Conditions4

Interventions1

Related trials

• A Phase II Clinical Study of AK104/AK112 in Combination With TT-00420 Tablet for Advanced HCC. — Akeso
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• A Study of Concurrent Chemoradiotherapy Followed by Cadonilimab（AK104） for Newly Diagnosed Local Advanced Cervical Cancer — West China Second University Hospital
• AK104 With Chemotherapy as Neoadjuvant and Adjuvant Therapy for Resectable Non-small Cell Lung Cancer — Henan Cancer Hospital
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• An Exploratory, Multi-cohort Phase II Study of Combination Therapy With AK104 and AK112 for Recurrent Ovarian Cancer — Akeso
• Efficacy and Safety of AK104 Combined With Chemotherapy and Recombinant Human Adenovirus 5 Injection in Cervical Cancer — Fujian Cancer Hospital

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