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OncoMatch/Clinical Trials/NCT06446726

Low-dose Radiation Combined With Neoadjuvant Immunochemotherapy for Esophageal Squamous Cell Carcinoma

Is NCT06446726 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Tislelizumab and Nab-paclitaxel for esophageal squamous cell carcinoma.

Phase 2RecruitingSichuan UniversityNCT06446726Data as of May 2026

Treatment: Tislelizumab · Nab-paclitaxel · CisplatinThis study aims to investigate the efficacy and safety of low-dose radiation combined with neoadjuvant chemotherapy and immunotherapy in the treatment of locally advanced thoracic esophageal squamous cell carcinoma. By reducing the radiation dose from 40 Gy in 20 fractions to 4 Gy in 2 fractions, the goal is to lessen the adverse reactions caused by radiotherapy. Additionally, the study explores whether low-dose radiation therapy can promote the cross-presentation of tumor-specific antigens and increase lymphocyte infiltration into the tumor site. Study also examines whether this approach can enhance tumor-specific immune responses, thereby potentially improving the efficacy of immune checkpoint inhibitors.

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Extracted eligibility criteria

Cancer type

Esophageal Carcinoma

Disease stage

Required: Stage CT1B-CT2 N1-2 M0, CT3-CT4A N0-2 M0

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

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

Cannot have received: chemotherapy

history of treatment for ESCC, including experimental drugs, chemotherapy, radiotherapy, or therapies targeting T-cell co-stimulation checkpoint pathways such as anti-PD-1, anti-PD-L1, anti-PD-L2 antibodies or drugs

Cannot have received: radiation therapy

history of treatment for ESCC, including experimental drugs, chemotherapy, radiotherapy, or therapies targeting T-cell co-stimulation checkpoint pathways such as anti-PD-1, anti-PD-L1, anti-PD-L2 antibodies or drugs

Cannot have received: checkpoint inhibitor (anti-PD-1, anti-PD-L1, anti-PD-L2)

history of treatment for ESCC, including experimental drugs, chemotherapy, radiotherapy, or therapies targeting T-cell co-stimulation checkpoint pathways such as anti-PD-1, anti-PD-L1, anti-PD-L2 antibodies or drugs

Lab requirements

Blood counts

White blood cells ≥ 3.5×10^9/L, ANC ≥1.5 ×10^9/L, Platelets ≥100×10^9/L, Hemoglobin ≥9g/dL

Kidney function

Serum creatinine ≤1.5×ULN, or creatinine clearance ≥ 60ml/min (Cockcroft/Gault formula)

Liver function

Total bilirubin ≤1.5 times ULN, ALT and/or AST ≤2.5 times ULN, Serum albumin ≥3g/dL

Cardiac function

No acute cardiac failure; no significant and severely symptomatic rhythm, conduction, or morphological abnormalities on ECG; no unstable angina, congestive heart failure, or chronic heart failure with NYHA ≥ 2

Adequate major organ and bone marrow function (without transfusion or medication correction): Complete blood count: White blood cells ≥ 3.5×10^9/L, Absolute Neutrophil Count (ANC) ≥1.5 ×10^9/L, Platelets ≥100×10^9/L, Hemoglobin ≥9g/dL; Liver function: Total bilirubin ≤1.5 times ULN, ALT and/or AST ≤2.5 times ULN, Serum albumin ≥3g/dL; Renal function: Serum creatinine ≤1.5×ULN, or creatinine clearance ≥ 60ml/min (Cockcroft/Gault formula); Pulmonary function: FEV1/FVC≥70%, FEV1≥50% of the normal value, DLCO >80%

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

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