A Phase III Study of AK104 as Adjuvant Therapy in HCC With High Risk of Recurrence After Curative Resection
NCT ID: NCT05489289
Last Updated: 2025-03-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
570 participants
INTERVENTIONAL
2023-01-05
2027-01-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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AK104
AK104 IV every three weeks
AK104
Subjects will receive AK104 until disease progression or for a maximum of 16 cycles
placebo
Placebo IV every three weeks
placebo
Subjects will receive placebo until disease progression or for a maximum of 16 cycles
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
75 Years
ALL
No
Sponsors
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Akeso
INDUSTRY
Responsible Party
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Principal Investigators
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Jia Fan, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Fudan University
Locations
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Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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AK104-306
Identifier Type: -
Identifier Source: org_study_id
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