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OncoMatch/Clinical Trials/NCT06385730

Neoadjuvant PD-1 Blockade for Elderly Esophageal Squamous Cell Carcinoma (BLESS)

Is NCT06385730 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including neoadjuvant anti-PD-1 and neoadjuvant anti-PD-1 with LDRT for esophageal cancer.

Phase 2RecruitingShanghai Chest HospitalNCT06385730Data as of May 2026

Treatment: neoadjuvant anti-PD-1 · neoadjuvant anti-PD-1 with LDRTThe investigators will conduct a prospective phase 2 study to evaluate the efficacy and safety of neoadjuvant PD-1 blockade monotherapy with toripalimab in elderly patients with locally advanced resectable esophageal squamous cell carcinoma (ESCC).

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Extracted eligibility criteria

Cancer type

Esophageal Carcinoma

Disease stage

Required: Stage T1N1-3M0, T2-3N0-3M0

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: radiotherapy

Have not received any anti-tumor treatment for esophageal cancer in the past, including radiotherapy, chemotherapy, surgery, etc.

Cannot have received: chemotherapy

Have not received any anti-tumor treatment for esophageal cancer in the past, including radiotherapy, chemotherapy, surgery, etc.

Cannot have received: surgery

Have not received any anti-tumor treatment for esophageal cancer in the past, including radiotherapy, chemotherapy, surgery, etc.

Cannot have received: immunotherapy

anti-tumor interventions such as radiotherapy, chemotherapy, immunotherapy or other medications

Lab requirements

Blood counts

NE ≥ 1.5×10^9/L; PLT ≥ 100×10^9/L; HGB ≥ 90 g/L

Kidney function

sCr ≤ 1.5×ULN or CrCl ≥ 50 mL/min (Cocheroft-Gault)

Liver function

bilirubin ≤ 1.5×ULN; ALT ≤ 2.5×ULN; AST ≤ 2.5×ULN

Blood routine: NE≥1.5×10^9/L; PLT≥100×10^9/L; HGB≥90 g/L; bilirubin≤ 1.5×ULN; ALT≤2.5×ULN; AST≤2.5×ULN; sCr≤1.5×ULN or CrCl≥50 mL/min(Cocheroft-Gault); INR≤1.5

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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