A phase 2 study to investigate efficacy, safety and pharmacokinetics of BGB-A317 in patients with inoperable liver cancer

A Phase 2, Open-label, Multicenter Study to Investigate the Efficacy, Safety, and Pharmacokinetics of the Anti-PD-1 Monoclonal Antibody BGB-A317 in Patients with Previously Treated Hepatocellular Unresectable Carcinoma

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-003983-10-DE

Enrollment

228

Registered

2017-12-27

Start date

2018-05-14

Completion date

Unknown

Last updated

2021-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Previously Treated Unresectable Hepatocellular Carcinoma MedDRA version: 21.0 Level: LLT Classification code 10019828 Term: Hepatocellular carcinoma non-resectable System Organ Class: 100000004864

Interventions

Product Name: Tislelizumab Product Code: BGB-A317 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Tislelizumab CAS Number: 1858168-59-8 Current Sponsor code: BGB-A317 O

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: 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	—

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

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Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: per protocol;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)	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: per protocol;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)

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Countries

China, France, Germany, Italy, Poland, Spain, Taiwan, United Kingdom, United States

Contacts

Public ContactBeiGene Clinical Support

BeiGene Ltd., c/o BeiGene USA, Inc.

BeigeneClinicalSupportUS@beigene.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026