OncoMatch/Clinical Trials/NCT06430658
Neoadjuvant Comprehensive Treatment for Unresectable Esophageal Cancer
Is NCT06430658 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Tislelizumab (BGB-A317) with chemoradiotherapy for esophagus cancer.
Treatment: Tislelizumab (BGB-A317) with chemoradiotherapy — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Esophageal Carcinoma
Disease stage
Required: Stage BORDERLINE UNRESECTABLE LOCALLY ADVANCED ESCC DEEMED BY INVESTIGATORS AS SUSPICIOUS OF BUT NOT CONFIRMED T4B ACCORDING TO THE AMERICAN JOINT COMMITTEE ON CANCER (AJCC) 8TH EDITION STAGING CLASSIFICATION OR EXTRACAPSULAR LYMPH NODE INVOLVEMENT (ELNI) (AJCC 8th edition)
Excluded: Stage M1 PER AJCC 8TH EDITION OF STAGING CLASSIFICATION, INCLUDING SUPRACLAVICULAR LYMPH NODE METASTASES
Borderline unresectable locally advanced ESCC deemed by investigators as suspicious of but not confirmed T4b according to the American Joint Committee on Cancer (AJCC) 8th edition staging classification or extracapsular lymph node involvement (ELNI). Baseline clinical stage M1 per AJCC 8th edition of staging classification, including supraclavicular lymph node metastases [excluded].
Prior therapy
Cannot have received: any anti-cancer treatment
Lab requirements
Blood counts
hemoglobin (Hb) ≥ 100g/L; white blood cell (WBC) ≥ 3.5×10^9/L; neutrophil count (NEUT) ≥ 1.5×10^9/L; platelets (PLT) ≥ 100×10^9/L
Kidney function
creatinine ≤ 1.5UNL; blood urea nitrogen (BUN) ≤ 1.0×UNL
Liver function
ALT and AST ≤ 1.5×UNL; total bilirubin (TBIL) ≤ 1.5×UNL
Normal primary organ functions, including but not limited to hemoglobin (Hb) ≥ 100g/L; white blood cell (WBC) ≥ 3.5×10^9/L; neutrophil count (NEUT) ≥ 1.5×10^9/L; platelets (PLT) ≥ 100×10^9/L; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 1.5×UNL; total bilirubin (TBIL) ≤ 1.5×UNL; creatinine ≤ 1.5UNL; blood urea nitrogen (BUN) ≤ 1.0×UNL.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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