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New treatment option for Hepatocellular Carcinoma
Official title A Phase III Study of AK104 as Adjuvant Therapy in HCC With High Risk of Recurrence After Curative Resection
ClinicalTrials.gov ID: NCT05489289
What this study is testing
What is AK104?
AK104 is an investigational medicine, being studied as a potential treatment for hepatocellular carcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The efficacy and safety of AK104 as adjuvant therapy in hepatocellular carcinoma of high recurrence risk after curative resection.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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;
You likely can't join if
- 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;
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.