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Compares treatment options for Hepatocellular Carcinoma
Official title A Study of AK104+Lenvatinib in Combination With Transarterial Chemoembolization (TACE) Versus TACE in Participants With Incurable/Non-metastatic Hepatocellular Carcinoma
ClinicalTrials.gov ID: NCT06371157
What this study is testing
What is AK104?
AK104 is an investigational medicine, given as an infusion into a vein, 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
- A study to evaluate cadonilimab (AK104) + lenvatinib in combination with transarterial chemoembolization (TACE) versus TACE in participants with incurable/non-metastatic hepatocellular carcinoma
- 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
- Has a diagnosis of HCC confirmed by histology/cytology，or meet the clinical diagnostic criteria of the American Association for the Study of Liver...
- No evidence of metastasis
- Not amenable to curative surgery or transplantation or curative ablation but amenable to TACE
- Child Pugh score class A
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment
You likely can't join if
- History of liver transplantation
- History of hepatic encephalopathy
- Uncontrolled arterial hypertension
- Deep venous thrombosis within 3 months before first treatment
- Bleeding events within the last 6 months
- Co-infection with HBV and HCV
See the full eligibility criteria
- Has a diagnosis of HCC confirmed by histology/cytology，or meet the clinical diagnostic criteria of the American Association for the Study of Liver Diseases (AASLD)
- No evidence of metastasis
- Not amenable to curative surgery or transplantation or curative ablation but amenable to TACE
- Child Pugh score class A
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment
- Measurable disease by RECIST 1.1
- Adequate organ function
- History of liver transplantation
- History of hepatic encephalopathy
- Uncontrolled arterial hypertension
- Deep venous thrombosis within 3 months before first treatment
- Bleeding events within the last 6 months
- Co-infection with HBV and HCV
The study team makes the final eligibility decision.
Where it's taking place
- Zhengzhou, Henan, China
- Changsha, Hunan, China
- Nanjing, Jiangsu, China
- Hangzhou, Zhejiang, 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 Zhengzhou, Henan, China; Changsha, Hunan, China; Nanjing, Jiangsu, China; Hangzhou, Zhejiang, 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.