NCT05489289RecruitingPhase 3
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
Source: ClinicalTrials.gov · Last updated 12 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The efficacy and safety of AK104 as adjuvant therapy in hepatocellular carcinoma of high recurrence risk after curative resection.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 570 (estimated)
- First submitted
- 4 Aug 2022
- Start date
- Jan 2023
- Primary completion date
- Jan 2026
- Lead sponsor
- Akeso
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT05489289
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 570
- From Jan 2023 to the primary completion date, Jan 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any anti-tumor treatment other than radical surgery before randomization;
Other illness
- 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;
Other
- Fibrolamellar hepatocellular carcinoma, sarcoma-like hepatocellular carcinoma, cholangiocarcinoma, etc;
- Precarious liver function indicated by severe complications;
- Pregnancy.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Zhongshan Hospital,Fudan University Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.