Phase 3 Study of Tislelizumab Versus Sorafenib in Participants With Unresectable HCC
Lay Description
This is a Phase 3, randomized, open-label, multicenter, global study designed to compare the efficacy and safety of tislelizumab versus sorafenib as a first-line systemic treatment in participants with unresectable hepatocellular carcinoma. This study also includes a substudy investigating the safety, tolerability, PK, and preliminary efficacy in HCC in Japanese participants. In Japan, preliminary safety and tolerability will be evaluated (Safety Run-In Substudy) before Japanese participants are recruited in this Phase 3 study.
Category
- Liver
- IRB Number
- 20180193HU
- NCT Number
- NCT03412773
- Open to Enrollment
- Yes
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Histologically confirmed diagnosis of HCC
- 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
- No prior systemic therapy for HCC (with the exception of HCC participants enrolled in the safety run-in substudy [Japan only])
- Measurable disease
- Child-Pugh score A
- Easter Cooperative Oncology Group (ECOG) Performance Status ≤ 1
- Adequate organ function
Key Ex
Exclusion Criteria
- Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC histology
- Tumor thrombus involving main trunk of portal vein or inferior vena cava
- Loco-regional therapy to the liver within 28 days before randomization
- Clinical evidence of portal hypertension with bleeding esophageal or gastric varices at Screening, or within 6 months before randomization
- 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
- Presence at Screening of active immune deficiency or autoimmune disease and/or prior history of any immune deficiency or autoimmune disease that may relapse
- Participant 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
- History of interstitial lung disease or non-infectious pneumonitis, unless induced by radiation therapy
- QT interval corrected for heart rate (QTc) (corrected by Fridericia's method) > 450 msec at Screening
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Study Design
Arm Groups
Study Contact
Regulatory Point of Contact
Sukeshi Arora
(210) 450-1015
aroras@uthscsa.edu
Regulatory Point of Contact
Frances Crawford
(210) 450-5037
crawfordf1@uthscsa.edu
Regulatory Point of Contact
Sonia Creighton
(210) 450-1366
creighton@uthscsa.edu
Regulatory Point of Contact
Myrna Montenegro
(210) 450-5954
montenegro@uthscsa.edu
Regulatory Point of Contact
Courtney Nichols
(210) 450-1794
nicholsc2@uthscsa.edu
Regulatory Point of Contact
Mailbox Ctrc Regulatory Affairs
regaffapp@uthscsa.edu
Regulatory Point of Contact
Regulatory Staff
regaffstaff@uthscsa.edu
Regulatory Point of Contact
Kathleen Rodriguez
(210) 450-1365
rodriguezk3@uthscsa.edu
Regulatory Point of Contact
Benjamin Schleif
(210) 450-1366
schleifb@uthscsa.edu
Regulatory Point of Contact
Morgan Seekatz
(210) 450-1133
seekatz@uthscsa.edu
Local Recruitment Point of Contact
Mailbox Ctrc Regulatory Affairs
regaffapp@uthscsa.edu
Principal Investigator
Sukeshi Arora