Health Trials

About this trial

This is a Phase II, open-label, single-arm, multicenter study evaluating the safety and efficacy of combining Tislelizumab with induction chemoradiotherapy (CRT), followed by conversion surgery, in patients with locally advanced, unresectable esophageal squamous cell carcinoma (ESCC).

Patients will receive induction CRT with weekly paclitaxel and cisplatin along with Tislelizumab, followed by two cycles of consolidation Tislelizumab-chemotherapy. If the tumor becomes resectable, patients will undergo surgery.

The primary goal is to assess the 2-year overall survival (OS) rate. Secondary outcomes include pathological complete response (pCR), conversion rate, R0 resection rate, disease-free survival (DFS), recurrence-free survival (RFS), and treatment-related adverse events.

Eligibility criteria

Qualifiers

Patients had histologically confirmed, squamous-cell carcinoma of the esophagus

Clinical T4 cancer, at least one unresectable metastatic regional lymph node due to invasion into an adjacent organ, or computed tomographic (CT) evidence of M1Lym, such as fixed supraclavicular nodes. Regional lymph nodes are defined on the basis of criteria specified by the eighth edition of the Union for International Cancer Control TNM staging system (Sobin and Wittekind, 2016).

An age of at least 20 years

An Eastern Cooperative Oncology Group performance-status score 0 or 1

Disqualifiers

Patient has received systemic therapy for advanced ESCC.

Patients had distant metastasis, including liver, lung, bone and brain metastases.

Patients had esophageal perforation or esophageal fistula

Patients had tumor bleeding

Trial design

Treatments tested in this trial

  • Tislelizumab
  • Paclitaxel
  • Cisplatin
  • Radiation Therapy

Treatment groups

45 Participants
are divided into 1 treatment group

Locations

8
Kaohsiung Chang Gung Memorial Hospital Kaohsiung City Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital Kaohsiung City Taiwan
China Medical University Hospital404, Taichung Taiwan
Taichung Veterans General Hospital407219, Taichung Taiwan

Sponsors and collaborators

Ming-Yu Lien

Lead sponsor

China Medical University Hospital

Sponsor institution

BeiGene

Collaborator

Source ClinicalTrials.gov