OncoMatch/Clinical Trials/NCT06061146
Tislelizumab Plus Concurrent Chemoradiation in Older With ESCC
Is NCT06061146 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Arm A and Arm A for esophageal cancer.
Treatment: Arm A · Arm A · Arm B — This study was conducted in elderly (≥70 years old) patients with locally advanced esophageal squamous cell carcinoma. Aim to find the difference in efficacy and safety between tirilizumab combined with concurrent chemoradiation and standard concurrent chemoradiation. Concurrent chemoradiation is the standard treatment for elderly esophageal cancer. Tirelizumab is the first-line and second-line standard treatment for advanced esophageal squamous carcinoma. However, the effect of tirilizumab combined with concurrent chemoradiation for elder with locally advanced esophageal squamous cell carcinoma is unkown. In the study, the investigators plan to enroll 136 elderly subjects with locally advanced esophageal cancer from five hospitals in China. The enrolled patients will be randomly divided into two groups: tirilizumab combined with concurrent chemoradiation group (Tislelizumab + radiotherapy + tigio) and concurrent chemoradiation group (radiotherapy + tigio). The treatment efficiency and safety will be evaluated.
Check if I qualifyExtracted eligibility criteria
Cancer type
Esophageal Carcinoma
Biomarker criteria
Required: PD-L1 (CD274) any tested (testing required; no eligibility threshold specified)
Disease stage
Required: Stage CT1N2-3M0, CT2-4BN0-3M0, CT1-4BN0-3M1 (SUPRACLAVICULAR LYMPH NODE METASTASIS), II, III, IVB (8th AJCC)
Histologically confirmed cT1N2-3M0 or cT2-4bN0-3M0 or cT1-4bN0-3M1(supraclavicular lymph node metastasis) locally advanced ESCC (8th AJCC ); Clinically staged as II-IVb inoperable locally advanced ESCC (including non-resectable, or with contraindications to or refusal of surgery)
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: systemic anti-tumor therapy
Haven't received any previous systemic anti-tumor therapy (including but not limited to systemic chemotherapy, radiotherapy, molecularly targeted drug therapy, immunotherapy, biologic therapy, topical therapy and other investigational therapeutic agents)
Cannot have received: anti-PD-1 therapy
Anti-PD-1 or anti-PD-L1 antibody therapy
Cannot have received: anti-PD-L1 therapy
Anti-PD-1 or anti-PD-L1 antibody therapy
Cannot have received: chemotherapy
chemotherapy
Cannot have received: radiotherapy
radiotherapy
Cannot have received: targeted therapy
targeted therapy
Cannot have received: investigational agent
Participation in a study of an investigational agent or device within 4 weeks before the first dose of study treatment
Cannot have received: anti-tumour vaccine
Received an anti-tumour vaccine or received a live vaccine within 4 weeks before the first dose of study treatment
Lab requirements
Blood counts
ANC ≥1500/μl, platelet count ≥100,000/μl and hemoglobin count ≥9.0 g/dl or ≥5.6 mmol/l
Kidney function
creatinine ≤1.5× ULN or measured or calculated creatinine clearance ≥60 mL/min for those with creatinine levels >1.5× ULN (Calculated from the Cockcroft-Gault formula)
Liver function
total bilirubin ≤1.5× ULN and ALT/AST/AKP levels ≤2.5× ULN and albumin ≥2.8 g/dl
Adequate hematologic function, defined as ANC ≥1500/μl, platelet count ≥100,000/μl and hemoglobin count ≥9.0 g/dl or ≥5.6 mmol/l; Adequate renal function, defined as creatinine ≤1.5× ULN or measured or calculated creatinine clearance ≥60 mL/min for those with creatinine levels >1.5× ULN (Calculated from the Cockcroft-Gault formula); Adequate hepatic function, defined as total bilirubin ≤1.5× ULN and ALT/AST/AKP levels ≤2.5× ULN and albumin ≥2.8 g/dl
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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