Phase 3
N=649
A Study of Tislelizumab (BGB-A317) in Combination With Chemotherapy as First Line Treatment in Participants With Advanced Esophageal Squamous Cell Carcinoma
Esophageal Squamous Cell Carcinoma (ESCC)
Bottom Line
View on ClinicalTrials.gov: NCT03783442 ↗Enrolled (actual)
649
Serious AEs
44.7%
Results posted
Nov 2023
Primary outcome: Primary: Overall Survival (OS) — 17.2; 10.6 months — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Cisplatin (Drug); Oxaliplatin (Drug); Fluorouracil (5-FU) (Drug); Capecitabine (Drug); Paclitaxel (Drug); Tislelizumab (Biological); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- BeiGene
- Primary completion
- Feb 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival (OS) |
17.2; 10.6 | <0.0001 sig |
| SECONDARY Progression-Free Survival (PFS) |
7.3; 5.6 | <0.0001 sig |
| SECONDARY Objective Response Rate (ORR) |
63.5; 42.4 | <0.0001 sig |
| SECONDARY Overall Survival (OS) in Participants With a PD-L1 Score ≥ 10% |
16.6; 10.0 | 0.0029 sig |
| SECONDARY Duration of Response (DOR) |
7.1; 5.7 | — |
| SECONDARY Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Oesophageal Cancer 18 Question Module (QLQ-OES18) Dysphagia, Eating, Reflux, Pain, and Index Scores |
-0.5; -4.9; -0.9; -1.5; -1.3; 0.2 | 0.1372 |
| SECONDARY Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30) Global Health Status/Quality of Life (GHS/QoL) and Physical Functioning Scales |
-0.3; -3.6; -4.8; -7.3 | — |
| SECONDARY Change From Baseline in EORTC QLQ-C30 Fatigue Scale |
8.0; 9.4 | — |
| SECONDARY Change From Baseline in European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Visual Analog Scale (VAS) |
-1.1; -3.1 | — |
| SECONDARY Number of Participants Experiencing Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) |
323; 319; 160; 128 | — |
Summary
The purpose of this study is to evaluate the efficacy and safety of tislelizumab as first line treatment in combination with chemotherapy in participants with advanced unresectable/metastatic esophageal squamous cell carcinoma (ESCC).
Eligibility Criteria
Key Inclusion Criteria
- Pathologically (histologically) confirmed diagnosis of ESCC
- Stage IV unresectable ESCC at first diagnosis OR unresectable, locally advanced recurrent or metastatic disease (per American Joint Committee on Cancer 7th Edition), if there is prior neoadjuvant/adjuvant therapy with platinum-based chemotherapy, a treatment-free interval of at least 6 months is required.
Key Exclusion Criteria
- Palliative radiation treatment for ESCC within 4 weeks of study treatment initiation
- Prior systemic therapy for unresectable, locally advanced recurrent or metastatic ESCC
- Received prior therapies targeting programmed cell death protein-1 (PD-1), programmed cell death protein ligand-1 (PD-L1) or PD-L2
- Participants with evidence of fistula (either esophageal/bronchial or esophageal/aorta)
- 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)
- Evidence of complete esophageal obstruction not amenable to treatment
- Unintentional weight loss ≥ 5% within one month prior to randomization or Nutritional Risk Index (NRI) < 83.5 per investigator's choice
- Locally advanced esophageal carcinoma that is resectable or potentially curable with radiation therapy per local investigator.
- Participants with untreated chronic hepatitis B or chronic hepatitis B virus (HBV) carriers whose HBV DNA is ≥ 500 IU/mL or participants with active hepatitis C virus (HCV)
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT03783442). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.