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Studies

Interventional Recruiting Phase 2

NCT07039162 on ClinicalTrials.gov

Study of Tislelizumab Combined With Chemoradiotherapy and Surgery for Unresectable Esophageal Squamous Cell Carcinoma

Official title: Phase II Study of Tislelizumab Combined With Induction Chemoradiotherapy and Subsequent Conversion Surgery for Locally Advanced Unresectable ESCC

  • Sponsor: Ming-Yu Lien
  • Collaborators: BeiGene
  • Enrollment: 45 (Estimated)
  • Study start: 2025-09-26 (Actual)
  • Primary completion: 2028-12-31 (Estimated)
  • Study completion: 2028-12-31 (Estimated)
  • Allocation: N/a
  • InterventionModel: Single Group
  • Masking: None
  • PrimaryPurpose: Treatment

Brief Summary

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.

Conditions

  • Esophageal Squamous Cell Carcinoma (ESCC)
  • Locally Advanced Unresectable Esophageal Cancer

Intervention / Treatment

  • Drug: Tislelizumab
  • Drug: Paclitaxel
  • Drug: Cisplatin
  • Radiation: Radiation Therapy

Primary Outcome Measures

  • 2-year OS rate (From the date of first treatment (induction chemoradiotherapy) to 2 years after treatment initiation.)
    Estimated 2-year OS rate is defined as number of participants alive divided by the number of participants.

Countries

Taiwan

Locations and Investigators

  • Kaohsiung Chang Gung Memorial Hospital, Kaohsiung City, Taiwan (Not yet recruiting)
    • Shau-Hsuan Li
  • Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung City, Taiwan (Not yet recruiting)
    • Yao-Kuang Wang
  • China Medical University Hospital, Taichung, Taiwan (Recruiting)
    • Ming-Yu Lien
  • Taichung Veterans General Hospital, Taichung, Taiwan (Not yet recruiting)
    • Cheng-Wei Chou, MD
  • National Cheng Kung University Hospital, Tainan, Taiwan (Not yet recruiting)
    • Chia-Jui Yen
  • National Taiwan University Hospital, Taipei, Taiwan (Not yet recruiting)
    • Chih-Hung Hsu, MD
  • Taipei Veterans General Hospital, Taipei, Taiwan (Not yet recruiting)
  • Linkou Chang Gung Memorial Hospital, Taoyuan District, Taiwan (Not yet recruiting)
    • Ming-Mo Hou, MD