CompletedPhase 3

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

United States, Australia, Belgium649 participantsStarted 2018-12-11

Plain-language 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).

Who can participate

Age range18 Years

SexALL

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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.

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.

What they're measuring

Overall Survival (OS)

Timeframe: From randomization to the primary analysis cutoff date of 28 February 2022; maximum time on follow-up was 3 years and 2 months.

Trial details

NCT IDNCT03783442

SponsorBeiGene

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-02-28

Results submitted2023-10-10

View on ClinicalTrials.gov More Esophageal Squamous Cell Carcinoma (ESCC) trials