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

RecruitingPhase 3Ages 18 Years - 75 YearsAllAkeso
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In plain words

What the trial is, and whether it could suit you

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

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๐Ÿ“‹ Eligibility rules (as published)
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.
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What it tests

  • AK104
  • placebo
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Where

1 site
Zhongshan Hospital, Fudan University
Shanghai, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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