Previously Treated Unresectable Hepatocellular Carcinoma MedDRA version: 21.0 Level: LLT Classification code 10019828 Term: Hepatocellular carcinoma non-resectable System Organ Class: 100000004864
Conditions
Interventions
Product Name: Tislelizumab
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Tislelizumab
CAS Number: 1858168-59-8
Sponsors
BeiGene Ltd., c/o BeiGene USA, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed HCC 2. Barcelona Clinic Liver Cancer (BCLC) Stage B or C disease not amenable to locoregional therapy or relapsed after locoregional therapy, and not amenable to a curative treatment approach 3. Has received at least 1 line of systemic therapy for unresectable HCC Measurable disease 4. Child-Pugh score A 5. Easter Cooperative Oncology Group (ECOG) Performance Status = 1 6. Adequate organ function Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 125 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 103
Exclusion criteria
Exclusion criteria: 1. Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC histology 2. Prior therapies targeting PD-1 or PD-L1 3. Has known brain or leptomeningeal metastasis 4. Tumor thrombus involving main trunk of portal vein or inferior vena cava 5. Loco-regional therapy to the liver within 4 weeks before enrollment 6. Medical history of interstitial lung disease, non-infectious pneumonitis or uncontrolled systemic diseases, including diabetes, hypertension, pulmonary fibrosis, acute lung diseases, etc 7. Has received: a. Within 28 days or 5 half-lives (whichever is shorter) of the first study drug administration: any chemotherapy, immunotherapy (eg, interleukin, interferon, thymoxin) or any investigational therapies b. Within 14 days of the first study drug administration: sorafenib, regorafenib, or any Chinese herbal medicine or Chinese patent medicines used to control cancer 8. Active autoimmune diseases or history of autoimmune diseases that may relapse. 9. 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 study drug administration
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of BGB-A317 through Independent Review Committee (IRC) assessed objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) Version (v)1.1 in previously treated, unresectable hepatocellular carcinoma (HCC); Secondary Objective: * To assess the efficacy of BGB-A317 through duration of response (DOR), progression-free survival (PFS), disease control rate (DCR), and clinical benefit rate (CBR) assessed by IRC and overall survival (OS) * To assess efficacy of BGB-A317 through ORR, DOR, PFS, DCR, and CBR assessed by the investigators * To further assess the safety and tolerability of BGB-A317 in patients with previously treated unresectable HCC * To assess the health-related quality of life (HRQoL) of BGB-A317 in patients with previously treated unresectable HCC ;Primary end point(s): ORR (complete response [CR] + partial response [PR]) based on RECIST Version 1.1 in patients with previously treated unresectable HCC as evaluated by an IRC;Timepoint(s) of evaluation of this end point: Per protocol | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): * DOR, PFS, DCR and CBR assessed by IRC, and OS * ORR, DOR. PFS, DCR and CBR assessed by Investigators * Safety and tolerability assessment of adverse events (AEs), serious adverse events (SAEs), physical examination, vital signs, electrocardiogram (ECG), and laboratory measurements * HRQoL measured using European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Hepatocellular Carcinoma 18 Questions (EORTC QLQ HCC18) index score, European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) index-score, and the 5-level version of the European Quality of Life 5-Dimensional Questionnaire (EQ-5D-5L) ;Timepoint(s) of evaluation of this end point: per protocol | — |
Countries
China, France, Germany, Italy, Poland, Spain, Taiwan, United Kingdom, United States
Contacts
Public ContactBeiGene Clinical Support
BeiGene Ltd., c/o BeiGene USA, Inc.
Outcome results
None listed