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OncoMatch/Clinical Trials/NCT06339619

Combination Immunotherapy of Adebrelimab With Apatinib and Tegafur for Immune Rechallenge Therapy in Esophageal Squamous Cell Carcinoma

Is NCT06339619 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Adebrelimab and Apatinib for locally advanced or metastatic esophageal squamous cell carcinoma.

Phase 2RecruitingSun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityNCT06339619Data as of May 2026

Treatment: Adebrelimab · Apatinib · TegafurThe goal of this single-arm study is to explore the efficacy and safety of Adebrelimab in combination with Apatinib and Tegafur for the treatment of locally advanced or metastatic esophageal squamous cell carcinoma that has failed first-line standard treatment with PD-1 inhibitors in combination with chemotherapy.

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Extracted eligibility criteria

Cancer type

Esophageal Carcinoma

Disease stage

Required: Stage III, DISTANT METASTASIS (AJCC 8th edition)

locally advanced unresectable or distant metastasis (according to AJCC 8th edition)

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Min 1 prior line

Must have received: immunotherapy combined with chemotherapy — first-line

Patients who have failed first-line immunotherapy combined with chemotherapy

Cannot have received: (Adebrelimab, Apatinib, Tegafur)

Patients who had previously received treament of Adebrelimab, Apatinib or Tegafur

Cannot have received: Chinese medicine anti-tumor treatment

Used Chinese medicine anti-tumor treatment within 2 weeks

Cannot have received: other anti-tumor therapy

Received other anti-tumor therapy within 4 weeks, including but not limited to chemotherapy, radiotherapy, and targeted therapy

Lab requirements

Blood counts

ANC≥1.5×10^9/L; PLT≥100×10^9/L; Hb≥90 g/L; Serum albumin ≥30 g/L

Kidney function

Cr ≤1.5×ULN, or creatinine clearance ≥50mL/min as calculated by the Cockcroft-Gault formula; Patients with urinary protein ≥++ should undergo further 24-hour quantitative detection of urinary protein, and the detection result should be<1.0g

Liver function

TBIL≤1.5×ULN; ALT and AST≤2.5 x ULN; For patients with liver metastases, ALT and AST≤5×ULN

Cardiac function

QTcF>470 ms; history of congenital long QT syndrome; history of any clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or torsades de pointes); left ventricular ejection fraction (LVEF) <50%

The functional level of the organ must meet the following requirements. (1) ANC≥1.5×10^9/L; (2) PLT≥100×10^9/L; (3) Hb≥90 g/L; (4) Serum albumin ≥30 g/L; (5) TBIL≤1.5×ULN; ALT and AST≤2.5 x ULN; For patients with liver metastases, ALT and AST≤5×ULN; (6) Cr ≤1.5×ULN, or creatinine clearance ≥50mL/min as calculated by the Cockcroft-Gault formula; (7) Patients with urinary protein ≥++ should undergo further 24-hour quantitative detection of urinary protein, and the detection result should be<1.0g. Fridericia-corrected QT interval (QTcF)>470 ms; history of congenital long QT syndrome; history of any clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or torsades de pointes); left ventricular ejection fraction (LVEF) <50%.

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

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