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RecruitingNCT05489289

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

A Randomized, Double-blind, Phase III Clinical Study on the Efficacy and Safety of AK104 Versus Placebo as Adjuvant Therapy for Hepatocellular Carcinoma With High Risk of Recurrence After Curative Resection

Status
Recruiting
Phase
Phase 3
Study type
Interventional
Enrollment
570 (estimated)
Sponsor
Akeso · Industry
Sex
All
Age
18 Years – 75 Years
Healthy volunteers
Not accepted

Summary

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

Conditions

Interventions

TypeNameDescription
BIOLOGICALAK104Subjects will receive AK104 until disease progression or for a maximum of 16 cycles
BIOLOGICALplaceboSubjects will receive placebo until disease progression or for a maximum of 16 cycles

Timeline

Start date
2023-01-05
Primary completion
2026-01-28
Completion
2027-01-01
First posted
2022-08-05
Last updated
2025-03-12

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT05489289. Inclusion in this directory is not an endorsement.

A Phase III Study of AK104 as Adjuvant Therapy in HCC With High Risk of Recurrence After Curative Resection (NCT05489289) · Clinical Trials Directory