Recruiting NCT05489289
A Phase III Study of AK104 as Adjuvant Therapy in HCC With High Risk of Recurrence After Curative Resection
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: AK104, placebo.
- Who it may be relevant to
- Registry conditions: Hepatocellular Carcinoma. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
The efficacy and safety of AK104 as adjuvant therapy in hepatocellular carcinoma of high recurrence risk after curative resection.
Interventions
- Biological AK104
Subjects will receive AK104 until disease progression or for a maximum of 16 cycles - Biological placebo
Subjects will receive placebo until disease progression or for a maximum of 16 cycles
Primary outcome measures
- Recurrence free survival (RFS) by BICR [Time frame: Up to 48 months]
Secondary outcome measures (5)
- 12-months recurrence free survival (RFS-12) [Time frame: 12 months]
- 24-months recurrence free survival (RFS-24) [Time frame: 24 months]
- Time to recurrence (TTR) [Time frame: Up to 48 months]
- Overall survival (OS) [Time frame: Up to 48 months]
- Types and proportions of adverse events (AEs) [Time frame: Up to 48 months]
Eligibility criteria
Inclusion criteria
- Pathological diagnosis of HCC without any metastasis;
- Receiving radical resection as the only anti-tumor treatment;
- No evidence of residual cancer found during or after the operation;
- Presence of any high risk factor of postoperative recurrence;
- Child-Pugh grade: A;
- ECOG score: 0;
- Controlled underlying causes of HCC.
Exclusion criteria
- Fibrolamellar hepatocellular carcinoma, sarcoma-like hepatocellular carcinoma, cholangiocarcinoma, etc;
- Any anti-tumor treatment other than radical surgery before randomization;
- Precarious liver function indicated by severe complications;
- Recent procedures or medications leading to high risk of bleeding;
- Poorly controlled or symptomatic hypertension, congestive heart failure, arrhythmia, etc;
- Failure of performing enhanced CT or MRI scans of the liver;
- Recent severe infections or systemic antibiotics use;
- Active autoimmune diseases;
- History of other incurable malignant tumors;
- History of transplantation;
- Pregnancy.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Zhongshan Hospital, Fudan University — Shanghai
Identifiers
NCT: NCT05489289 · AK104-306