Study of Tislelizumab in Participants With Resectable Esophageal Squamous Cell Carcinoma (NCT04974047) | Clinical Trial Compass
CompletedPhase 2
Study of Tislelizumab in Participants With Resectable Esophageal Squamous Cell Carcinoma
China70 participantsStarted 2021-08-17
Plain-language summary
The purpose of this study is to evaluate the pathological complete response (pCR) in participants receiving tislelizumab plus chemotherapy/chemoradiotherapy as neoadjuvant treatment.
Who can participate
Age range18 Years
SexALL
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Key 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.
Key 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, targeted therapy agents, 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 sys…
What they're measuring
1
Pathological Complete Response (pCR) Rate
Timeframe: pCR was determined from samples taken during surgery; surgery occurred 4-6 weeks after the last dose of chemotherapy, approximately Day 71-86