Pembrolizumab Combined With Preoperative Chemotherapy (Albumin Paclitaxel+Carboplatin) Neoadjuvant Therapy for Resectable Locally Advanced (Stage II/III) Esophageal Squamous Cell Carcinoma

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorTongji University

About this trial

This study is a prospective, single center, open label, single arm clinical study. Select resectable locally advanced (cT3-4aN0M0, cT1-3N1-2M0, cII/III stage) esophageal cancer with pathological diagnosis of squamous cell carcinoma for inclusion, receive pembrolizumab combined with platinum containing dual drug (albumin paclitaxel+carboplatin) treatment for 2 courses, and undergo surgery. After surgery, continue pembrolizumab immunotherapy. Using pCR as the main endpoint of the study

Eligibility criteria

Qualifiers

Baseline stage resectable cII/III esophageal squamous cell carcinoma (8th UICC TNM stage);

Failure to receive anti-tumor treatment for esophageal squamous cell carcinoma;

Age range from 18 to 75 years old;

There are no surgical contraindications in the preoperative evaluation of various organ functions;

Disqualifiers

Individuals who have received previous treatment for esophageal cancer (surgery, radiotherapy, chemotherapy, immunotherapy, targeted therapy, etc.);

Not suitable for surgery or with surgical contraindications;

Have a history of other anti PD-L1/PD-1 treatments;

Individuals with immunodeficiency or long-term systemic steroid therapy, or those who have received any immunosuppressive therapy within 7 days prior to receiving the study drug;

Trial design

Treatments tested in this trial

  • Combination of pembrolizumab and platinum containing dual drugs

Treatment groups

25 Participants
are divided into 1 treatment group

Sponsors and collaborators