A Randomized, Open-label, Multicenter Phase 3 Study to Compare the Efficacy and Safety of BGB-A317 Versus Sorafenib as First-Line Treatment in Patients With Unresectable Hepatocellular Carcinoma
Phase: PHASE3
Conditions: Hepatocellular Carcinoma (HCC)
Sponsor: BeiGene

BeiGene 
11 May 2020 
CONFIDENTIAL 
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CLINICAL RESEARCH PROTOCOL 
Protocol Title: 
A Randomized, Open-label, Multicenter Phase 3 Study to Compare the Efficacy 
and Safety of BGB-A317 versus Sorafenib as First-Line Treatment in Patients 
with Unresectable Hepatocellular Carcinoma 
Protocol Identifier: 
BGB-A317-301 
Phase: 
3 
Investigational Product: 
Tislelizumab (BGB-A317) 
Reference Number 
EudraCT 2017-002423-19 
Indication: 
Unresectable Hepatocellular Carcinoma 
Sponsor: 
BeiGene, Ltd. 
c/o BeiGene USA, Inc. 
1900 Powell Street 
Suite 820 
Emeryville, CA 94608 
USA 
Sponsor Medical Monitors: 
 
 
 
 
 
 
 
 
 
 
 
 
 
Original Date: 
05 July 2017 
Amendment No. (Date): 
1.0 (13 September 2017)  
Amendment No. (Date) 
2.0 (03 October 2017)  
Amendment No. (Date) 
3.0 (18 October 2017)  
Amendment No. (Date) 
4.0 (28 June 2018)  
Amendment No. (Date) 
5.0 (11 May 2020) 
NCT: NCT03412773
BGB-A317-301 
Protocol Amendment 5.0 

BGB-A317-301 
BeiGene 
Protocol Amendment 5.0 
11 May 2020 
CONFIDENTIAL 
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Confidentiality Statement 
This Document Is Not for Distribution – Do Not Copy 
This document contains confidential information and is the proprietary property of BeiGene, 
Ltd., and its subsidiaries. This document is for use by individuals and their designated 
representatives for their confidential review, consideration, and/or participation in investigational 
trial(s). This document may not be copied or distributed for review by any unauthorized 
individuals without the prior written authorization of BeiGene, Ltd., or one of its subsidiaries. 
Your acceptance of this document constitutes agreement that you will not disclose the 
information contained herein to others without the prior written authorization from BeiGene, 
Ltd., or one of its subsidiaries. 

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1. Written informed consent is required prior to performing any study-specific tests or procedures. Results of standard of care tests or examinations performed 
prior to obtaining informed consent and within 28 days prior to randomization may be used for Screening assessments rather than repeating such tests. 
2. The End of Treatment Visit is conducted when the investigator determines that tislelizumab or sorafenib will no longer be used. If routine laboratory tests 
(eg, hematology, serum chemistry) are completed within 7 days before the End of Treatment Visit, tests need not be repeated. Tumor assessment is not 
required at the End of Treatment Visit provided that fewer than 6 weeks have passed since the last assessment. 
3. The Safety Follow-up Visit is required to be conducted 30 days (± 7 days) after the last dose of tislelizumab or sorafenib, or before the initiation of a new 
anticancer treatment, whichever occurs first. In the situation where study treatment is withheld/interrupted for 30 days or more prior to permanent 
discontinuation of study treatment (End of Treatment Visit), the Safety Follow-up Visit should be conducted at the same time as the End of Treatment Visit. 
Common procedures to both visits should be performed only once. 
4. Survival Follow-up information will be collected via telephone calls, patient medical records, and/or clinic visits approximately every 3 months (± 14 days) 
after the Safety Follow-up Visit until death, loss to follow-up, withdrawal of consent, or study termination by sponsor. All patients will be followed for 
survival and subsequent anticancer therapy information unless a patient requests to be withdrawn from follow-up. 
5. Patients will be randomized into either the tislelizumab or sorafenib arms via IRT. All patients are required to receive study treatment within 2 days of 
randomization. 
6. Includes age or date of birth, gender, and self-reported race/ethnicity; history of treatment for the primary diagnosis, including prior medication, loco-
regional treatment(s), and surgical treatment(s). Information on radiographic studies performed prior to study entry may be collected for review by the 
investigator. 
7. Patients are required to have Child-Pugh A classification for liver function assessed within 7 days before randomization. 
8. Vital signs collected on study include temperature, pulse rate, and blood pressure (systolic and diastolic) while the patient is in a seated position after resting 
for 10 minutes. The patient’s vital signs are required to be recorded within 60 minutes before; during; and 30 minutes after the first infusion of tislelizumab. 
For subsequent infusions, vital signs will be collected within 60 minutes before infusion and if clinically indicated, during and 30 minutes (up to + 15 
minutes) after the infusion.  
For patients randomized to the sorafenib arm, monitor blood pressure weekly during the first 6 weeks after the first dose. Thereafter, monitor blood pressure 
at Day 1 of every cycle. Investigator may perform additional or more frequent blood pressure assessments if clinically indicated. 
9. The ECG recordings will be obtained during Screening, the Safety Follow-up Visit, and as clinically indicated at other time points. Patients should be resting 
for at least 10 minutes prior to each ECG collection. Additional ECG monitoring should be performed following local guidance based on the sorafenib 
labeling. Abnormal ECGs should be repeated in triplicate. 
10. The AEs and laboratory abnormalities will be graded per NCI-CTCAE v4.03. All AEs will also be evaluated for seriousness. After the informed consent 
form has been signed, but prior to the administration of study drug, only SAEs should be reported. After the first dose of study drug, all AEs and SAEs, 
regardless of relationship to study drug, will be reported until either 30 days after the last dose of study treatment (including sorafenib) or the initiation of 
new anticancer therapy, whichever occurs first. Immune-related AEs (serious and nonserious) will be reported for 90 days after the last dose of tislelizumab, 
regardless of whether or not the patient starts a new anticancer therapy. All drug-related SAEs will be recorded by the investigator after treatment 
discontinuation until patient death or loss to follow-up, whichever occurs first. 
After a patient has been discontinued from the study drug(s), investigators are not obligated to actively seek AEs or SAEs in former patients. However, if the 
investigator learns of any SAE, including a death, and he/she considers the SAE related to the study drug, the investigator will notify the sponsor as 
described in Table 5 in Section 8.7.2.1. 
11. Local or central laboratory assessments on serum chemistry, hematology, coagulation, and urinalysis will be conducted, of which certain elements will be 
collected as specified in Appendix 5. Investigators in regions where central labs are required may also use results from local laboratories for assessing 
eligibility, safety monitoring and dosing decision. If laboratory tests at screening (hematology, chemistry, coagulation, urinalysis, and alpha fetoprotein) are 
not performed within 7 days of randomization, these tests should be repeated and reviewed before randomization. Patients with electrolyte deficiencies, 

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including magnesium, potassium, and calcium, must have these clinically corrected in the screening period before enrollment in the study. Hematology and 
serum chemistry (including liver function tests) will be performed weekly for the first 3 cycles and then at the beginning of subsequent cycles (data collected 
as specified in Appendix 5). After Cycle 1, results are to be reviewed within 48 hours before study drug administration. Urinalysis is to be conducted during 
the treatment period only if clinically warranted. Refer to Section 8.4.5 for additional information regarding clinical assessment and management of clinical 
laboratory abnormalities. 
12. Includes international normalized ratio, prothrombin time, and activated partial thromboplastin time. 
13. Urine or serum pregnancy test (for women of childbearing potential, including women who have had a tubal ligation) must be performed and documented as 
negative within 7 days prior to randomization. If screening pregnancy test is > 7 days prior to randomization, it must be repeated at Cycle 1 Day 1, prior to 
dosing. Urine pregnancy tests will be performed at each visit prior to dosing. A serum pregnancy test must be performed if the urine pregnancy test is 
positive or equivocal. 
14. Analysis of FT3, FT4, and TSH will be performed by a central laboratory or the local study site laboratory. Thyroid function tests will be performed at 
Screening and every 3 cycles (ie, Day 1 of Cycles 4, 7, 10, et cetera), and at the Safety Follow-up Visit. 
15. Only for patients randomized to tislelizumab treatment. Procedures for collection of PK samples are described in the Laboratory Manual. Predose (within 60 
minutes before starting infusion) samples are required to be collected at Day 1 of Cycles 1, 2, 5, 9 and 17; A postdose (within 30 minutes after completing 
tislelizumab infusion) sample is required to be collected at Day 1 of Cycles 1 and 5. An additional PK sample is required to be collected at the Safety 
Follow-up. Should a patient present with any ≥ Grade 3 irAE, an additional blood PK sample may be taken to determine the serum concentration of 
tislelizumab. These tests are required when it is allowed by local regulations/IRBs/ECs. 
16. Patients who are suspected or known to have serious/severe respiratory conditions or exhibit significant respiratory symptoms unrelated to the underlying 
cancer will have pulmonary function testing which may include, but is not limited to, spirometry and assessment of diffusion capacity done during the 
Screening period to assist the determination of suitability on the study. At least 50% of performance expected by age is required for spirometry (including 
FVC and FEV1). Assessment of diffusion capacity during Screening is required in patients with a history of thoracic radiotherapy or restrictive lung disease. 
When DLCO is performed, at least 60% of performance expected by age is required. 
17. Blood used to test for anti-tislelizumab antibodies should be collected within 60 minutes before beginning the Day 1 infusion of Cycles 1, 2, 5, 9, and 17 and 
at the mandatory Safety Follow-up Visit. All samples should be drawn at the same time as blood collection for predose PK analysis. These tests are required 
when it is allowed by local regulations/IRBs/ECs. 
18. Testing will be performed by a central laboratory and/or the local laboratory at Screening and will include HBV/HCV serology (HBsAg, HBsAb, HBcAb, 
and HCV antibody) and viral load assessment (HBV DNA and HCV RNA). Patients who have detectable HBV DNA or HCV RNA at Screening will 
perform the respective viral load test every 4 cycles (ie, Day 1 of Cycle 5, 9, 13, etc). 
19. Radiological images captured as standard of care prior to obtaining written informed consent and within 28 days of randomization may be used rather than 
repeating tests. All measurable and evaluable lesions are required to be assessed and documented at the Screening Visit. An MRI (or CT scan if MRI is 
contraindicated or not readily available) of the head may be required at screening based on clinical judgement; bone scan or 18F-NaF PET is required if 
clinically indicated. The same radiographic procedure must be used throughout the study for each patient.  
The investigator must review radiograph results before dosing at the following cycle. Patients will undergo tumor assessments approximately every 9 weeks 
(± 7 days) during Year 1 and every 12 weeks (± 7 days) from Year 2 onwards (based on RECIST v1.1 assessment). The investigator may perform additional 
scans or more frequent assessments if clinically indicated. See Section 7.4 for more information. Patients who discontinue study treatment early for reasons 
other than disease progression (eg, toxicity) will continue to undergo tumor assessments following the original plan until the patient experiences disease 
progression, withdraws consent, dies, or until the study terminates, whichever occurs first. Patients who continue tislelizumab/sorafenib treatment beyond 
radiographic disease progression (Section 7.13.1) will be monitored with a follow-up scan no more than 6 to 8 weeks beyond the initial diagnosis of 
radiographic PD before discontinuation of tislelizumab/sorafenib treatment. 

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20. Patients are required to provide archival tumor tissues (FFPE blocks or approximately 10 [≥ 5] unstained slides) for biomarker analysis (except if not 
allowed by local regulations/IRBs/IECs). 
21. Fresh biopsy: In the absence of archival tumor tissues, a fresh biopsy of a tumor lesion at baseline is optional (written informed consent is required prior to 
fresh tumor biopsies). See Section 7.6 for more information. 
22. Tislelizumab will be given IV Q3W. The initial infusion (Cycle 1, Day 1) will be delivered over 60 minutes, and then can be administered over 30 minutes 
for subsequent infusions if well tolerated. Patients must be monitored for 2 hours after infusion of tislelizumab on Day 1 of Cycle 1 and Cycle 2, from Cycle 
3 onward, at least a 30-minute monitoring period is required. The first dose will be given on Cycle 1 Day 1 and subsequent dosing will continue on the 
original 21-day treatment interval schedule. Each cycle has a (±) 3-day window, however in case of dose delays there should be a minimum of 14 days 
between tislelizumab dosing days. 
23. Sorafenib will be self-administered PO at the recommended dose of 400 mg (2 tablets of 200 mg) BID, without food (at least 1 hour before or 2 hours after a 
meal). 
24. To be completed prior to any clinical activities that are performed that day during on-study site visits. EQ5D-5L, EORTC QLQ-C30, and EORTC QLQ-
HCC18 will be completed at Screening and/or baseline, at every other cycle through Cycle 12, then every 4 cycles thereafter, and at EOT. 
25. Eye exam, visual acuity test, and optical coherence tomography (or equivalent diagnostic test for retinal examination) captured as standard of care prior to 
obtaining written informed consent and within 28 days of randomization may be used rather than repeating tests. Eye exam, visual acuity test, and optical 
coherence tomography (or equivalent diagnostic test) will be assessed by an ophthalmologist at the Screening Visit in all patients. Patients treated with 
tislelizumab will undergo repeat assessments approximately every 15 weeks (± 7 days) 
26. Patients treated with tislelizumab: The ophthalmologic assessments including eye exam, visual acuity test, and optical coherence tomography (or equivalent 
diagnostic test) should only be performed once at either the EOT or during safety follow-up, within 30 days of study treatment end. 
27. Investigators should solicit patients regarding changes in vision, visual disturbance, or ocular inflammation at each scheduled study visit during tislelizumab 
treatment. For any change in vision, referral to an ophthalmologist will be made for further management guidance. New or worsened clinically significant 
abnormalities are to be recorded as AEs on the eCRF. 
28. Review of AEs and concomitant medications may be conducted by telephone on Days 8 and 15. 
Abbreviations: AE, adverse event; AFP, alpha fetoprotein; BID, twice daily; DLCO, diffusing capacity for carbon monoxide; DNA, deoxyribonucleic acid; ECG, 
electrocardiogram; ECOG, Eastern Cooperative Oncology Group; EORTC QLQ-HCC18, European Organisation for Research and Treatment of Cancer Quality 
of Life Questionnaire-Hepatocellular Carcinoma-18 Questions; EORTC QLQ-C30, European Organisation for Research and Treatment of Cancer Quality of Life 
Questionnaire-Core 30; EQ-5D-5L, 3-level European Quality of Life 5-Dimensions (health questionnaire); FEV1, forced expiratory volume in the first second of 
expiration; FFPE, formalin-fixed paraffin-embedded; FVC, forced vital capacity; HBcAb, hepatitis B core antibody; HBsAg, hepatitis B surface antigen; HBV, 
hepatitis B virus; HCV, hepatitis C virus; HBsAb, hepatitis B surface antibody; irAE, immune-related adverse event; IRT, interactive response technology; IV, 
intravenous; MRI, magnetic resonance imaging; 18F-NaF PET, 18F-sodium fluoride position emission tomography; NCI-CTCAE, National Cancer Institute 
Common Terminology Criteria for Adverse Events; PK, pharmacokinetic; PO, orally; Q3W, once every 3 weeks; RECIST, Response Evaluation Criteria in Solid 
Tumors; RNA, ribonucleic acid; SAE, serious adverse event; TEAE, treatment-emergent adverse event; TSH, thyroid stimulating hormone; v, version.

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After a patient has been discontinued from the study drug(s), investigators are not obligated to actively seek AEs or SAEs in former patients. However, if the 
investigator learns of any SAE, including a death, and he/she considers the SAE related to the study drug, the investigator will notify the sponsor as 
described in Table 5 in Section 8.7.2.1 of the main protocol. 
9. Local or central laboratory assessments on serum chemistry, hematology, coagulation, and urinalysis will be conducted, of which certain elements will be 
collected as specified in Appendix 5. If laboratory tests at screening (hematology, chemistry, coagulation, urinalysis, and alpha fetoprotein) are not 
performed within 7 days prior to the administration of study drug on Cycle 1 Day 1, these tests should be repeated and reviewed before study drug 
administration. Patients with electrolyte deficiencies, including magnesium, potassium, and calcium, must have these clinically corrected in the screening 
period before enrollment in the study. Hematology and serum chemistry (including liver function tests) will be performed weekly through the end of the 28-
day DLT assessment period. After the DLT assessment period, hematology and serum chemistry (including liver function tests) will be performed weekly 
for Cycle 2 and Cycle 3 and then at the beginning of subsequent cycles from Cycle 4 and beyond (data collected as specified in Appendix 5). After Cycle 1, 
results are to be reviewed within 48 hours before study drug administration. Urinalysis is to be conducted during the treatment period only if clinically 
warranted. Refer to Section 8.4.5 of the main protocol for additional information regarding clinical assessment and management of clinical laboratory 
abnormalities. 
10. Includes international normalized ratio, prothrombin time, and activated partial thromboplastin time. 
11. Urine or serum pregnancy test (for women of childbearing potential, including women who have had a tubal ligation) must be performed and documented as 
negative within 7 days prior to enrollment. If screening pregnancy test is > 7 days prior to enrollment, it must be repeated at Cycle 1 Day 1, prior to dosing. 
Urine pregnancy tests will be performed at each visit prior to dosing. A serum pregnancy test must be performed if the urine pregnancy test is positive or 
equivocal. 
12. Analysis of FT3, FT4, and TSH will be performed by a central laboratory or local study site laboratory. Thyroid function tests will be performed at 
Screening and every 3 cycles (ie, Day 1 of Cycles 4, 7, 10, et cetera), and at the Safety Follow-up Visit. 
13. Patients who are suspected or known to have serious/severe respiratory conditions or exhibit significant respiratory symptoms unrelated to the underlying 
cancer will have pulmonary function testing which may include but is not limited to spirometry and assessment of diffusion capacity done during the 
Screening period to assist the determination of suitability on the study. At least 50% of performance expected by age is required for spirometry (including 
FVC and FEV1). Assessment of diffusion capacity during Screening is required in patients with a history of thoracic radiotherapy or restrictive lung disease. 
When DLCO is performed, at least 60% of performance expected by age is required. 
14. Refer to Appendix 13 Table 2 for details on timing of pharmacokinetics sample collection. Procedures for collection of PK samples are described in the Lab 
Manual. All predose samples should be drawn at the same time as blood collection for anti-tislelizumab antibodies. Intensive PK at Cycle 1 and Cycle 5; 
Sparse PK at Cycle 2, 3, 7, 9, 13, 17, 25 and 33, and every 8 cycles thereafter. An additional PK sample is required to be collected at the Safety Follow-up 
Visit. Should a patient present with any ≥ Grade 3 immune-related AE, an additional blood PK sample may be taken to determine the serum concentration of 
tislelizumab. 
15. Blood used to test for anti-tislelizumab antibodies should be collected within 60 minutes before beginning the Day 1 infusion of Cycles 1, 2, 3, 5, 7, 9, 13, 
17, 25, 33, every 8 cycles thereafter, and at the mandatory Safety Follow-up. All samples should be drawn at the same time as blood collection for predose 
PK analysis. 
16. Testing will be performed by a central laboratory and/or the local laboratory at Screening and will include HBV/HCV serology (HBsAg, HBsAb, HBcAb, 
and HCV antibody) and viral load assessment (HBV DNA and HCV RNA). Patients who have detectable HBV DNA or HCV RNA at Screening will 
perform the respective viral load test every 4 cycles (ie, Day 1 of Cycle 5, 9, 13, et cetera). 
17. Radiological images captured as standard of care prior to obtaining written informed consent and within 28 days of enrollment may be used rather than 
repeating tests. All measurable and evaluable lesions are required to be assessed and documented at the Screening Visit. An MRI (or CT scan if MRI is 
contraindicated or not readily available) of the head may be required at screening based on clinical judgement; bone scan or 18F-NaF PET is required if 
clinically indicated. The same radiographic procedure must be used throughout the study for each patient. The investigator must review radiograph results 

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before dosing at the following cycle. Patients will undergo tumor assessments every 9 weeks (± 7 days) during Year 1 and every 12 weeks (± 7 days) from 
Year 2 onwards (based on RECIST v1.1 assessment). The investigator may perform additional scans or more frequent assessments if clinically indicated. 
See Section 7.4 of the main protocol for more information. 
Patients who discontinue study treatment early for reasons other than disease progression (eg, toxicity) will continue to undergo tumor assessments 
following the original plan until the patient experiences disease progression, withdraws consent, dies, or until the study terminates, whichever occurs first. 
Patients who continue treatment with tislelizumab beyond radiographic disease progression will be monitored with a follow-up scan no more than 6 to 8 
weeks beyond the initial diagnosis of radiographic PD before discontinuation of tislelizumab treatment 
18. Patients are required to provide archival tumor tissues (FFPE blocks or approximately 10 [≥ 5] unstained slides) for biomarker analysis (except if not 
allowed by local regulations/IRBs/IECs). 
19. Fresh biopsy: In the absence of archival tumor tissues, a fresh biopsy of a tumor lesion at baseline is optional (written informed consent is required prior to 
fresh tumor biopsies). See Section 7.6 of the main protocol for more information. 
20. Tislelizumab will be given IV Q3W. The initial infusion (Cycle 1, Day 1) will be delivered over 60 minutes, and then can be administered over 30 minutes 
for subsequent infusions if well tolerated. Patients must be monitored for 2 hours after infusion of tislelizumab on Day 1 of Cycle 1 and Cycle 2, from Cycle 
3 onward, at least a 30-minute monitoring period is required. The first 6 patients will remain hospitalized during the first week of the first cycle of treatment. 
The first dose will be given on Cycle 1 Day 1 and subsequent dosing will continue on the original 21-day treatment interval schedule. Each cycle has a (±) 3-
day window, however in case of dose delays there should be a minimum of 14 days between tislelizumab dosing days. 
21. To be completed prior to any clinical activities that are performed that day during on-study site visits. EQ5D-5L, EORTC QLQ-C30, and EORTC QLQ-
HCC18 will be completed at Screening, and/or baseline, at every other cycle through Cycle 12, then every 4 cycles thereafter, and at EOT. 
22. Eye exam, visual acuity test, and optical coherence tomography (or equivalent diagnostic test for retinal examination) captured as standard of care prior to 
obtaining written informed consent and within 28 days of randomization may be used rather than repeating tests. Eye exam, visual acuity test, and optical 
coherence tomography (or equivalent diagnostic test) will be assessed by an ophthalmologist at the Screening Visit. Patients will undergo repeat assessments 
approximately every 15 weeks (± 7 days) 
23. The ophthalmologic assessments including eye exam, visual acuity test, and optical coherence tomography (or equivalent diagnostic test) should only be 
performed once at either the EOT or during safety follow-up within 30 days of study treatment end. 
24. Investigators should solicit patients regarding changes in vision, visual disturbance, or ocular inflammation at each scheduled study visit during tislelizumab 
treatment. For any change in vision, referral to an ophthalmologist will be made for further management guidance. 
25. Review of AEs and concomitant medications may be conducted by telephone on Days 8 and 15 
Abbreviations: ADA, antidrug antibody; AE, adverse event; AFP, alpha fetoprotein; DLCO, diffusing capacity for carbon monoxide; DNA, deoxyribonucleic 
acid; ECG, electrocardiogram; ECOG, Eastern Cooperative Oncology Group; EORTC QLQ-HCC18, European Organisation for Research and Treatment of 
Cancer Quality of Life Questionnaire–Hepatocellular Carcinoma 18 Questions; EORTC QLQ-C30, European Organisation for Research and Treatment of 
Cancer Quality of Life Questionnaire-Core 30; EQ-5D-5L, 5-level European Quality of Life 5-Dimensions (health questionnaire); FEV1, forced expiratory 
volume in the first second of expiration; FFPE, formalin-fixed paraffin-embedded; FVC, forced vital capacity; HBV, hepatitis B virus; HCV, hepatitis C virus; 
HBcAb, hepatitis B core antibody; HBsAb, hepatitis B surface antibody; HBsAg, hepatitis B surface antigen; irAE, immune-related adverse event; IV, 
intravenously; MRI, magnetic resonance imaging; 18F-NaF PET, 18F-sodium fluoride position emission tomography; NCI-CTCAE, National Cancer Institute 
Common Terminology Criteria for Adverse Events; PK, pharmacokinetic(s); Q3W, once every 3 weeks; RECIST, Response Evaluation Criteria in Solid Tumors; 
SAE, serious adverse event; SpO2, peripheral oxygen saturation RNA, ribonucleic acid; TEAE, treatment-emergent adverse event; TSH, thyroid stimulating 
hormone; v, version.