NCT03783442|CompletedPhase 3ResultsDMCFDA Drug

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

A Randomized, Placebo-Controlled, Double-Blind Phase 3 Study to Evaluate the Efficacy and Safety of Tislelizumab (BGB-A317) in Combination With Chemotherapy as First-Line Treatment in Patients With Unresectable, Locally Advanced Recurrent or Metastatic Esophageal Squamous Cell Carcinoma

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4 other identifiers

BGB-A317-3062018-000587-28CTR20181013JapicCTI-194741

Study Type

interventional

Target

649

Locations

16 countries

Sites

124

Timeline

RegisteredDec 2018

StartedDec 2018

CompletionAug 2024

Brief 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).

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network

Enrollment

649

participants targeted

Target at P75+ for phase_3

Timeline

Completed

Started Dec 2018

Longer than P75 for phase_3

Geographic Reach

16 countries

124 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

5.7 years study duration

Study Start

First participant enrolled

December 11, 2018

Completed

7 days until next milestone

First Submitted

Initial submission to the registry

December 18, 2018

Completed

3 days until next milestone

First Posted

Study publicly available on registry

December 21, 2018

Completed

3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2022

Completed

1.7 years until next milestone

Results Posted

Study results publicly available

November 7, 2023

Completed

10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 22, 2024

Completed

Last Updated

July 29, 2025

Status Verified

July 1, 2025

Enrollment Period

3.2 years

First QC Date

December 18, 2018

Results QC Date

October 10, 2023

Last Update Submit

July 28, 2025

Conditions

Esophageal Squamous Cell Carcinoma (ESCC)

Outcome Measures

Primary Outcomes (1)

Overall Survival (OS)
Overall survival is defined as the time from the date of randomization until the date of death due to any cause. Median OS was estimated using the Kaplan-Meier method. Primary analysis (data cut-off date of 28 February 2022) was the pre-defined analysis at which the primary endpoint was tested for superiority.
From randomization to the primary analysis cutoff date of 28 February 2022; maximum time on follow-up was 3 years and 2 months.

Secondary Outcomes (9)

Progression-Free Survival (PFS)
From randomization to the primary analysis cutoff date of 28 February 2022; maximum time on follow-up was 3 years and 2 months.
Objective Response Rate (ORR)
Response was assessed every 6 weeks for the first 48 weeks, then every 9 weeks thereafter; up to the primary analysis cutoff date of 28 February 2022; maximum time on follow-up was 3 years and 2 months.
Overall Survival (OS) in Participants With a PD-L1 Score ≥ 10%
From randomization to the primary analysis cutoff date of 28 February 2022; maximum time on follow-up was 3 years and 2 months.
Duration of Response (DOR)
From randomization to the primary analysis cutoff date of 28 February 2022; maximum time on follow-up was 3 years and 2 months.
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
Baseline, Cycle 6 (Week 15)
+4 more secondary outcomes

Study Arms (2)

Tislelizumab + Chemotherapy

EXPERIMENTAL

Participants received tislelizumab 200 milligrams (mg) administered intravenously (IV) on Day 1 of each 3-week treatment cycle together with an investigator-chosen chemotherapy doublet until unacceptable toxicity, disease progression or withdrawal for other reasons. Chemotherapy options were a platinum agent (cisplatin 60-80 mg/m² intravenously on Day 1 or oxaliplatin 130 mg/m² intravenously on Day 1) combined with a fluoropyrimidine (fluorouracil \[750-800 mg/m² intravenously on Days 1-5\] or capecitabine \[1000 mg/m² orally twice daily on Days 1-14\]) or paclitaxel (175 mg/m² intravenously on Day 1).

Drug: CisplatinDrug: OxaliplatinDrug: Fluorouracil (5-FU)Drug: CapecitabineDrug: PaclitaxelBiological: Tislelizumab

Placebo + Chemotherapy

ACTIVE COMPARATOR

Participants received placebo administered IV on Day 1 of each 3-week treatment cycle together with an investigator-chosen chemotherapy doublet until unacceptable toxicity, disease progression or withdrawal for other reasons. Chemotherapy options were a platinum agent (cisplatin 60-80 mg/m² intravenously on Day 1 or oxaliplatin 130 mg/m² intravenously on Day 1) combined with a fluoropyrimidine (fluorouracil \[750-800 mg/m² intravenously on Days 1-5\] or capecitabine \[1000 mg/m² orally twice daily on Days 1-14\]) or paclitaxel (175 mg/m² intravenously on Day 1).

Drug: CisplatinDrug: OxaliplatinDrug: Fluorouracil (5-FU)Drug: CapecitabineDrug: PaclitaxelDrug: Placebo

Interventions

CisplatinDRUG

Cisplatin 60-80 mg/m² administered by intravenous infusion every 3 weeks. Cisplatin was used as the platinum agent in China, Taiwan, and Japan.