Neoadjuvant Comprehensive Treatment for Unresectable Esophageal Cancer
Condition(s) studied
Investigational drug(s) / intervention(s)
Tislelizumab (BGB-A317) with chemoradiotherapy: Different sequences and methods of treatment to convert surgery
Study summary
Patients diagnosed with locally advanced esophageal squamous cell carcinoma (ESCC) that is deemed unresectable face a bleak prognosis. Recent phase 1/2 studies have demonstrated the efficacy and safety of augmenting neoadjuvant concurrent chemoradiotherapy with immunotherapy in treating resectable ESCC. The present study is a prospective, 3-arm, randomized trial that seeks to evaluate the efficacy of diverse conversion therapy modalities in patients with unresectable ESCC. The study objectives include R0 resection rate, treatment-related adverse events, morbidity and mortality, 1-year progression-free survival (PFS), and 1-year overall survival (OS) rates.
Tislelizumab is a humanized IgG4 monoclonal antibody with high affinity/specificity for programmed cell death protein 1 (PD-1). Tislelizumab was specifically engineered to minimize binding to FcɤR on macrophages, thereby abrogating antibody-dependent phagocytosis, a potential mechanism of T-cell clearance and resistance to anti-PD-1 therapy.
This trial will provide valuable insights into the effectiveness of the three conversion therapy modalities and help to inform clinical decision-making for patients with unresectable locally advanced ESCC.
Eligibility
Primary outcome measure(s)
- R0 resection rate — 4 months
Minimal distance tumor/circumferential resection margin (CRM) \> 1 mm.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Department of Radiation Oncology, Cancer Hospital, National Cancer Center, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC) | Beijing | China | Recruiting |
More Cancer Institute and Hospital, Chinese Academy of Medical Sciences trials in China
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06430658 on ClinicalTrials.gov ↗ ← All trials in China