A Phase 2 interventional study of AK104+lenvatinib and lenvatinib in HCC and Hepatocellular Carcinoma, sponsored by Akeso. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-22.
Sponsored by Akeso · Phase 2, Interventional, and Treatment
This is a Phase II, randomized, open-label, global, multi-center study to compare the efficacy and safety of AK104 in combination with lenvatinib versus lenvatinib in patients with advanced hepatocellular carcinoma who have progressed on the first line treatment of atezolizumab and bevacizumab.
6,738 studies on the registry are indexed under Carcinoma; 1,159 are open to participants now.
This study's planned enrollment of 120 is above the median of 45 across 5,167 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →Akeso is the lead sponsor of 154 studies on the registry; 67 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
AK104 IV plus lenvatinib orally
Biological: AK104+lenvatinib
lenvatinib orally
Drug: lenvatinib
Subjects will receive AK104+lenvatinib until disease progression
Subjects will receive lenvatinib until disease progression
Objective Response Rate (ORR) per RECIST v1.1 by Blinded Independent Central Review (BICR)
Proportion of subjects who have a complete or partial response relative to baseline as assessed by BICR according to RECIST v1.1.
Time frame: Up to 24 months
Overall Survival (OS)
OS is defined as the time from randomization to death due to any cause.
Time frame: Up to 24 months
Progression-free survival (PFS) assessed by investigator per RECIST v1.1
PFS is defined as the time from randomization till the first documented disease progression (Per RECIST v1.1 assessed by the investigator) or death due to any cause, whichever occurs first.
Time frame: Up to 24 months
Duration of Response (DOR) assessed by investigator per RECIST v1.1
DOR means time measured from the date of partial or complete response to therapy until the cancer progresses based on RECIST v1.1 criteria.
Time frame: Up to 24 months
Time to Response (TTR) assessed by investigator per RECIST v1.1
TTR refers to Time to Response.
Time frame: Up to 24 months
Number of participants with adverse event (AE)
The number of participants experiencing an Adverse Event (AE) and the severity of AEs will be assessed. AE refers to any untoward medical occurrence or deterioration of existing medical event after the subject signed the ICF, whether or not considered related to the study treatment.
Time frame: Up to 24 months
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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