Pembrolizumab Plus Paclitaxel Cisplatin Followed by Surgery for Locally Advanced ESCC

  • STATUS
    Recruiting
  • participants needed
    50
  • sponsor
    Tianjin Medical University Cancer Institute and Hospital
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Updated on 16 February 2024
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serum pregnancy test
pembrolizumab
squamous cell carcinoma
paclitaxel
carcinoma
urine test
squamous cell carcinoma of esophagus
pembrolizumab injection
cisplatin

Summary

The purpose of this study is to observe and evaluate the efficacy and safety of pembrolizumab plus paclitaxel, cisplatin followed by Da Vinci robot radical surgery for locally advanced esophageal squamous cell carcinoma.

Description

The Preoperative chemoradiotherapy with surgery is the standard treatment in NCCN guideline. But many patients refused or abandon radiotherapy because of the intolerable adverse effects. We designed a single-arm, open-label, phase II trial of pembrolizumab plus paclitaxel, cisplatin followed by Da Vinci robot radical surgery for locally advanced (stage III) esophageal squamous cell cancer. The purpose of this study is to observe and evaluate the efficacy and safety.

Details
Condition Esophageal Cancer, Esophageal Cancer, Squamous cell carcinoma, Squamous cell carcinoma, Stage III
Age 18years - 70years
Treatment Pembrolizumab Injection [Keytruda]
Clinical Study IdentifierNCT04389177
SponsorTianjin Medical University Cancer Institute and Hospital
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

Histologically confirmed esophageal squamous cell carcinoma
Potentially resectable cT3N1M0cT1-3N2M0(stage III)
PD-L1(+)CPS10
ECOG: 0~1
Age 18-70 years old, both men and women

Exclusion Criteria

Prior therapy (operation, radiotherapy, immunotherapy, or chemotherapy) for esophageal cancer
Ineligibility or contraindication for esophagectomy
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug
Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs)
Has severe hypersensitivity and adverse events (Grade 3) to nivolumab and/or any PD-1/PD-L1 inhibitors
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