Study of Tislelizumab in Participants With Resectable Esophageal Squamous Cell Carcinoma

  • STATUS
    Recruiting
  • End date
    May 30, 2026
  • participants needed
    65
  • sponsor
    BeiGene
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Updated on 13 March 2022
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Summary

The purpose of this study is to evaluate the pathological complete response (pCR) in participants receiving tislelizumab plus chemotherapy/chemoradiotherapy as neoadjuvant treatment.

Details
Condition Resectable Esophageal Squamous Cell Carcinoma
Treatment tislelizumab
Clinical Study IdentifierNCT04974047
SponsorBeiGene
Last Modified on13 March 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

Eastern Cooperative Oncology Group Performance Status of 0 or 1
Histologically confirmed esophageal squamous cell carcinoma (ESCC)
Stage cT1-2N+M0 and cT3NanyM0 (per The American Joint Committee on Cancer 8th Edition)
Evaluation by the investigator to confirm eligibility for an R0 resection with curative intent
Adequate hematologic and organ function, defined by protocol-specified laboratory test results obtained within 14 days before first dose

Exclusion Criteria

Ineligible for treatment with any of the chemotherapy doublets of protocol-specified chemotherapy
Any prior therapy for current ESCC, including investigational agents, chemotherapy, radiotherapy, or prior therapy with an anti-programmed cell death protein-1, anti-programmed cell death protein ligand-1, anti-programmed cell death protein ligand-2, or any other antibody or drug specifically targeting T-Cell co-stimulation or checkpoint pathways
History of fistula due to primary tumor invasion
Participants with high risk of fistula or sign of perforation evaluated by investigator
Any condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone or equivalent) or other immunosuppressive medications within 14 days before first dose
Adrenal replacement steroid (dose ≤ 10 mg daily of prednisone or equivalent) and topical, ocular, intra-articular, intranasal, or inhaled corticosteroid with minimal systemic absorption, and short course (≤ 7 days) of corticosteroid prescribed prophylactically or for the treatment of a non-autoimmune condition are permitted
Active autoimmune diseases or history of autoimmune diseases that may relapse
Controlled Type I diabetes, hypothyroidism only requiring hormone replacement, controlled celiac disease, skin diseases (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll
History of interstitial lung disease, non-infectious pneumonitis or uncontrolled
With infections requiring systemic antibacterial, antifungal, or antiviral therapy, including tuberculosis infection
diseases including pulmonary fibrosis, acute lung diseases
Severe infections within 4 weeks before first dose, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia
Receive therapeutic oral or intravenous antibiotics within 2 weeks before first dose
Note: Other protocol defined Inclusion/Exclusion criteria may apply
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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