Neoadjuvant Immunochemotherapy and Chemoradiotherapy Followed by Surgery for Advanced Esophageal Squamous Cell Carcinoma

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorNational Taiwan University Hospital

About this trial

Effective systemic therapy such as nivolumab as an adjuvant therapy has been demonstrated to improve the outcomes of patients receiving neoadjuvant chemoradiotherapy (CRT) for locoregional esophageal cancer. A more effective systemic therapy with anti-PD-1 or anti-PD-L1 immune checkpoint inhibitors (ICIs) plus cisplatin-based doublet chemotherapy, which has shown with high tumor response rate and improved survivals in patients with late-stage ESCC, may provide crucial benefit to patients with locally advanced disease by improving the systemic control, downstaging the locoregional tumor burden and reducing recurrence and metastasis.

Collectively, the investigators hypothesize that total neoadjuvant therapy (TNT) approach-consisting of induction immunochemotherapy followed by CRT-is a promising strategy to enhance the outcomes for participants with locally advanced esophageal squamous cell carcinoma.

Eligibility criteria

Qualifiers

Pathologically proven squamous cell carcinoma of the intrathoracic esophagus.

cT3/4a, N0, M0;

cT1-4a, N1-3, M0.

Tumor length longitudinal ≤ 10cm and radial ≤ 5cm.

Disqualifiers

Adenocarcinoma

Previous thoracic irradiation

Previous systemic chemotherapy

Has received prior therapy with an anti-PD-1 or anti-PD-L1

Trial design

Treatments tested in this trial

  • Tislelizumab
  • Paclitaxel
  • Cisplatin
  • Chemoradiotherapy

Treatment groups

50 Participants
are divided into 1 treatment group

Locations

1
National Taiwan University Hospital100229, Taipei Taiwan

Sponsors and collaborators

National Taiwan University Hospital

Lead sponsor

BeiGene

Collaborator