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

  • STATUS
    Recruiting
  • End date
    Jan 30, 2022
  • participants needed
    622
  • sponsor
    BeiGene
Updated on 23 September 2020
Investigator
Eric Hedrick, MD
Primary Contact
Subei People's Hospital (2.0 mi away) Contact
+204 other location
paclitaxel
carcinoma
fluorouracil
squamous cell carcinoma
oxaliplatin
capecitabine

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 ESCC.

Details
Treatment Capecitabine, cisplatin, Placebo, Paclitaxel, Oxaliplatin, Fluorouracil (5-Fu), tislelizumab, Platinum (cisplatin or oxaliplatin) + Fluorouracil (5-FU), Platinum (cisplatin or oxaliplatin) + capecitabine, Platinum (cisplatin or oxaliplatin) + paclitaxel
Clinical Study IdentifierNCT03783442
SponsorBeiGene
Last Modified on23 September 2020

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Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Squamous cell carcinoma or Esophageal Cancer or Esophageal Squamous Cell Carcinoma?
Pathologically (histologically) confirmed diagnosis of ESCC
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

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
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