A Study of Tislelizumab (BGB-A317) Versus Chemotherapy as First Line Treatment in Patients With Advanced Esophageal Squamous Cell Carcinoma

Patients with unresectable, locally advanced recurrent or metastatic ESCC who have Stage IV
unresectable ESCC at first diagnosis (ie, Stage IV disease at the original diagnosis of
ESCC) or who have unresectable, locally advanced recurrent or metastatic disease with at
least a 6-month treatment-free interval, if prior definitive therapy (chemotherapy,
chemo-radiation therapy or surgery) was given.

Inclusion Criteria:

1. Pathologically (histologically) confirmed diagnosis of ESCC

2. Stage IV unresectable ESCC at first diagnosis OR unresectable, locally advanced
recurrent or metastatic disease with a treatment free interval of at least 6 months
after definitive treatment.

Exclusion Criteria:

1. Palliative radiation treatment for ESCC within 4 weeks of study treatment initiation

2. Prior systemic therapy for unresectable, locally advanced recurrent or metastatic ESCC

3. Received prior therapies targeting PD-1, PD-L1 or PD-L2

4. Patients with evidence of fistula (either esophageal/bronchial or esophageal/aorta)

5. Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent
drainage or medical intervention (clinically significant recurrence requiring an
additional intervention within 2 weeks of intervention)

6. Evidence of complete esophageal obstruction not amenable to treatment

7. Unintentional weight loss ≥ 5% within one month prior to randomization or other
indicators of severe malnutrition (Severe malnutrition may be determined using the
Nutritional Risk Index (Shirasu, et al. 2018))

8. Patients receiving chemotherapy doublet C (platinum and paclitaxel) must not have
peripheral neuropathy ≥ Grade 2 at baseline

9. Patients who recur after definitive surgery and are eligible for non-palliative
radiation therapy and/or chemoradiotherapy.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.