Phase 2
Completed N=64
Preliminary Antitumor Activity, Safety and Tolerability of Tislelizumab in Combination With Lenvatinib for Hepatocellular Carcinoma
Source: ClinicalTrials.gov NCT04401800 ↗Enrolled (actual)
64
Serious AEs
17.2%
Results posted
Mar 2025
Primary outcomePrimary: Overall Response Rate (ORR) as Assessed by Central Imaging Facility Based on RECIST v1.1 — 38.7 percentage of participants — p=0.0002
Summary
The primary objective of this study was to assess the preliminary antitumor activity as indicated by overall response rate (ORR) of tislelizumab in combination with lenvatinib in participants with unresectable locally advanced or metastatic hepatocellular carcinoma (HCC) by central site imaging facility per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Response Rate (ORR) as Assessed by Central Imaging Facility Based on RECIST v1.1 |
38.7 | 0.0002 sig |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs) and TEAEs Leading to Treatment Discontinuation and Modification |
64; 11; 4; 37 | — |
| SECONDARY Objective Response Rate (ORR) as Assessed by the Investigator Based on RECIST v1.1 |
41.9 | < 0.0001 sig |
| SECONDARY Objective Response Rate (ORR) as Assessed by the Investigator and Central Site Imaging Facility Based on Modified Response Evaluation Criteria in Solid Tumors (mRECIST) |
46.8; 46.8 | < 0.0001 sig |
| SECONDARY Objective Response Rate (ORR) as Assessed by the Investigator and Central Site Imaging Facility Based on Immune Related Response Evaluation Criteria in Solid Tumors (iRECIST) |
43.5; 38.7 | < 0.0001 sig |
| SECONDARY Duration of Response (DOR) As Assessed by The Investigator Based on RECIST v1.1 |
NA | — |
| SECONDARY Duration of Response (DOR) As Assessed by The Central Site Imaging Facility Based on RECIST v1.1 |
NA | — |
| SECONDARY Duration of Response (DOR) As Assessed by The Investigator Based on mRECIST |
9.7 | — |
| SECONDARY Duration of Response (DOR) As Assessed by the Central Site Imaging Facility Based on mRECIST |
NA | — |
| SECONDARY Duration of Response (DOR) As Assessed by The Investigator Based on iRECIST |
NA | — |
| SECONDARY Duration of Response (DOR) As Assessed by The Central Site Imaging Facility Based on iRECIST |
NA | — |
| SECONDARY Disease Control Rate (DCR) As Assessed by The Investigator and Central Site Imaging Facility Based on RECIST v1.1 |
85.5; 90.3 | — |
| SECONDARY Disease Control Rate (DCR) As Assessed by The Investigator and Central Site Imaging Facility Based on mRECIST |
85.5; 90.3 | — |
| SECONDARY Disease Control Rate (DCR) As Assessed by The Investigator and Central Site Imaging Facility Based on iRECIST |
88.7; 90.3 | — |
| SECONDARY Progression Free Survival (PFS) As Assessed by The Investigator Based on RECIST v1.1 |
9.6 | — |
| SECONDARY Progression Free Survival (PFS) As Assessed by The Central Site Imaging Facility Based on RECIST v1.1 |
8.2 | — |
| SECONDARY Progression Free Survival (PFS) As Assessed by The Investigator Based on mRECIST |
6.9 | — |
| SECONDARY Progression Free Survival (PFS) As Assessed by The Central Site Imaging Facility Based on mRECIST |
8.3 | — |
| SECONDARY Progression Free Survival (PFS) As Assessed by The Investigator Based on iRECIST |
11.1 | — |
| SECONDARY Progression Free Survival (PFS) As Assessed by The Central Site Imaging Facility Based on iRECIST |
8.2 | — |
Eligibility Criteria
Key Inclusion Criteria
- Able to provide written informed consent and can understand and agree to comply with the requirements of the study and the schedule of assessments
- Unresectable locally advanced or metastatic HCC, which must be confirmed by histologically or cytologically. Fibrolamellar, sarcomatoid, or mixed cholangiocarcinoma histology confirmed by histologically or cytologically is excluded.
- Barcelona Clinic Liver Cancer (BCLC) Stage C disease or BCLC Stage B disease that is not amenable to or has progressed after loco-regional therapy and is not amenable to a curative treatment approach
- Did not receive any systemic treatment before and is unwilling to accept standard of care treatment or not suitable for standard of care treatment as judged by investigators
- At least 1 measurable lesion as defined by RECIST v1.1
- European Cancer Oncology Group (ECOG) Performance Status ≤ 1
- Child-Pugh A classification for liver function assessed within 7 days of first dose of study drugs
Key Exclusion Criteria
- Active autoimmune diseases or history of autoimmune diseases that may relapse
- Any active malignancy ≤ 2 years before the first dose of study drugs except for specific cancer under investigation in this study and any locally recurring cancer that has been treated curatively (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast)
- Uncontrolled diabetes or > Grade 1 laboratory test abnormalities in potassium, sodium, or corrected calcium despite standard medical management, or ≥ Grade 3 hypoalbuminemia ≤ 14 days before the first dose of study drugs
- Any known brain or leptomeningeal metastases
- Concurrent participation in another therapeutic clinical study
NOT: Other protocol defined Inclusion/Exclusion criteria may apply NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT04401800). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.