Unresectable Hepatocellular Carcinoma MedDRA version: 21.0 Level: LLT Classification code 10019828 Term: Hepatocellular carcinoma non-resectable System Organ Class: 100000004864
Conditions
Sponsors
BeiGene, Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed diagnosis of HCC 2. Barcelona Clinic Liver Cancer (BCLC) Stage B or C disease not amenable to or progressing after loco-regional therapy and not amenable to a curative treatment approach 3. No prior systemic therapy for HCC (with the exception of HCC patients enrolled in the safety run-in substudy [Japan only]) 4. Measurable disease 5. Child-Pugh score A 6. Easter Cooperative Oncology Group (ECOG) Performance Status = 1 7. Adequate organ function Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 402 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 268
Exclusion criteria
Exclusion criteria: 1. Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC histology 2. Tumor thrombus involving main trunk of portal vein or inferior vena cava 3. Loco-regional therapy to the liver within 28 days before randomization 4. Clinical evidence of portal hypertension with bleeding esophageal or gastric varices at Screening, or within 6 months before randomization 5. Bleeding or thrombotic disorder or any prescribed anticoagulant requiring therapeutic international normalized ratio monitoring (eg, warfarin or similar agents) at Screening, or within 6 months before randomization/enrollment 6. Presence at Screening of active immune deficiency or autoimmune disease and/or prior history of any immune deficiency or autoimmune disease that may relapse 7. Patient with any condition requiring systemic treatment with either corticosteroids (> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication within 14 days before randomization 8. History of interstitial lung disease or non-infectious pneumonitis, unless induced by radiation therapy 9. QT interval corrected for heart rate (QTc) (corrected by Fridericia’s method) > 450 msec at Screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare OS between Tislelizumab and sorafenib as first-line treatment in patients with unresectable HCC;Secondary Objective: •To compare ORR assessed by Blinded Independent Review Committee (BIRC) according to Response Evaluation Criteria in Solid Tumors [RECIST]) Version (v)1.1 between Tislelizumab and sorafenib • To compare progression-free survival (PFS) assessed by BIRC according to RECIST v1.1 between Tislelizumab and sorafenib • To compare DOR assessed by BIRC according to RECIST v1.1 between Tislelizumab and sorafenib • To compare time to progression (TTP) between Tislelizumab and sorafenib • To compare health-related quality of life (HRQoL) between Tislelizumab and sorafenib • To compare tumor assessment outcomes (ie, ORR, PFS, DOR, TTP) assessed by Investigator according to RECIST v1.1 between Tislelizumab and sorafenib • To compare disease control rate (DCR) and clinical benefit rate (CBR), assessed by BIRC and Investigator according to RECIST v1.1, between Tislelizumab and sorafenib • To compare safety and tolerability of Tislelizumab versus sorafenib;Primary end point(s): • Overall Survival (OS) – defined as the time from the date of randomization to the date of death due to any cause;Timepoint(s) of evaluation of this end point: OS assessed by Blinded Independent Review Committee (BIRC) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Overall Response Rate (ORR) as assessed by BIRC – defined as the proportion of patients with a documented CR or PR per RECIST v1.1 • Progression-free survival (PFS)– defined as the time from the date of randomization to the date of the first objectively documented tumor progression, assessed by BIRC per RECIST v1.1, or death, whichever occurs first • Duration of response (DOR) – defined as the time from the first determination of an objective response, assessed by BIRC per RECIST v1.1, until the first documentation of progression or death, whichever occurs first • Time to progression (TTP) – defined as the time from the date of randomization to the date of the first objectively documented tumor progression, assessed by BIRC per RECIST v1.1 • Health-related quality of life (HRQoL) • Tumor assessment (ie, ORR, PFS, DOR and TTP), assessed by Investigator per RECIST v1.1 • Disease control rate (DCR) – defined as the proportion of patients whose best overall response (BOR) is CR, PR, or SD, assessed by BIRC and Investigator per RECIST v1.1 • Clinical benefit rate (CBR) – defined as the proportion of patients who have CR, PR, or SD of = 24 weeks in duration, assessed by BIRC and Investigator per RECIST v1.1 • Safety assessment ;Timepoint(s) of evaluation of this end point: • ORR by BIRC • PFS by BIRC • DOR by BIRC • TTP by BIRC • HRQoL • Tumor assessments (ORR, PFS, DOR, and TTP) assessed by Investigator per RECIST v1.1 • DCR by BIRC and Investigator • CBR by BIRC and Investigator • Safety assessment (eg, new adverse events [AEs], AEs present at baseline that worsen in severity during the study, and clinical laboratory abnormalities) | — |
Countries
China, European Union, France, Germany, Japan, Spain, Taiwan, United Kingdom, United States
Contacts
Public ContactBeiGene Clinical Support
BeiGene, Inc.
Outcome results
None listed