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OncoMatch/Clinical Trials/NCT06885814

Efficacy and Safety of Adebrelimab Combined With Chemoradiotherapy in Patients With Unresectable Locally Advanced or Postoperative Recurrent Esophageal Squamous Cell Carcinoma

Is NCT06885814 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Adebrelimab: 20mg/kg day1, Q3W, 3 times for esophageal squamous cell carcinoma.

Phase 2RecruitingNanfang Hospital, Southern Medical UniversityNCT06885814Data as of May 2026

Treatment: Adebrelimab: 20mg/kg day1, Q3W, 3 timesThis study was a single-center, single-arm, open-label phase II clinical trial. Thirty patients with unresectable locally advanced or postoperative recurrent esophageal squamous cell carcinoma were treated with concurrent chemoradiotherapy combined with immunotherapy. The radiotherapy regimen was intensity-modulated radiotherapy with PGTV at 50-50.4 Gy/25-28 fractions, 1.8-2 Gy per fraction, five times a week. The chemotherapy regimen was paclitaxel 50 mg/m2 and cisplatin 25 mg/m2 intravenous infusion on day 1, once a week for five times. The immunotherapy was with adebutilimab at 20 mg/kg on day 1, every three weeks for three times. One week before radiotherapy, gastroscopy, chest CT or PET-CT images were taken as the baseline standard. Based on the results of gastroscopy, chest CT or PET-CT before and after treatment, the number of patients with complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD) in the two groups was observed. The objective response rate (ORR) was calculated as CR + PR, and the disease control rate (DCR) was calculated as CR + PR + SD. The progression-free survival (PFS), overall survival (OS), 1-year and 2-year survival rates and adverse reactions were also statistically analyzed.

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Extracted eligibility criteria

Cancer type

Esophageal Carcinoma

Biomarker criteria

Required: PD-L1 (CD274) any tested (testing required; no eligibility threshold specified)

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Cannot have received: PD-1 or PD-L1 antibody therapy

previously received PD-1 or PD-L1 antibody therapy

Cannot have received: immunosuppressive drugs or corticosteroids >10mg/day prednisone

Exception: within 14 days prior to enrollment

Patients receiving immunosuppressive drugs or corticosteroids >10mg/ day of prednisone therapeutic dose within 14 days prior to enrollment

Cannot have received: radiotherapy, chemotherapy, targeted therapy, or immunotherapy

Exception: within 4 weeks prior to enrollment

Patients who had received radiotherapy, chemotherapy, targeted therapy, or immunotherapy within 4 weeks prior to enrollment

Lab requirements

Blood counts

neutrophils ≥1.5 x 10^9/L, platelets ≥100 x 10^9/L; Hemoglobin ≥ 9g/L; Albumin ≥ 2.8g/dL

Liver function

Bilirubin ≤1.5 times ULN, ALT and AST≤2.5 times ULN

Laboratory examination: neutrophils ≥1.5 x 10^9/L, platelets ≥100 x 10^9/L; Hemoglobin ≥ 9g/L; Albumin ≥ 2.8g/dL; Bilirubin ≤1.5 times ULN, ALT and AST≤2.5 times ULN

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

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