OncoMatch

OncoMatch/Clinical Trials/NCT06385730

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

Is NCT06385730 recruiting? Yes, currently enrolling (Jun 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 Jun 2026Location: China

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).

Check if I qualify

Extracted eligibility criteria

Treatments studied

Other

neoadjuvant anti-PD-1neoadjuvant anti-PD-1 with LDRT

Cancer type

Esophageal Carcinoma

Disease stage

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

Performance status

ECOG 0–1(Restricted strenuous activity)

Demographics

Ages ≥ 76

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.

Frequently asked questions

Is NCT06385730 currently recruiting?

Yes, this trial is currently recruiting patients.

Can patients have received prior systemic therapy?

No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.

What disease stage is eligible?

Stage T1N1-3M0 or T2-3N0-3M0 is required.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

Check if I qualify