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

Last updated: April 13, 2026
Sponsor: Nanfang Hospital, Southern Medical University
Overall Status: Active - Recruiting

Phase

2

Condition

Lung Cancer

Esophageal Cancer

Squamous Cell Carcinoma

Treatment

Adebrelimab: 20mg/kg day1, Q3W, 3 times

Clinical Study ID

NCT06885814
NFEC-2024-242
  • Ages 18-75
  • All Genders

Study Summary

This 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age 18-75 years old, gender unlimited

  2. Esophageal squamous cell carcinoma confirmed by histology and unresectable locallyadvanced or postoperative recurrence

  3. According to the solid tumor efficacy evaluation criteria (RECIST1.1), there is atleast one measurable lesion; And the lesion had not received prior radiotherapy

  4. ECOG: 0~1

  5. Expected survival ≥12 weeks 6. Laboratory examination: neutrophils ≥1.5 x 109/L,platelets ≥100 x 109/L; Hemoglobin ≥ 9g/L; Albumin ≥ 2.8g/dL; Bilirubin ≤1.5 timesULN, ALT and AST≤2.5 times ULN

7: Subjects voluntarily joined the study, signed informed consent, had good compliance, and cooperated with follow-up 8: Tissue samples should be provided for biomarker analysis such as (PD-L1). Newly acquired tissues are preferred, and 15 5-6um thick paraffin sections can not be provided for archiving by the recent organizer

Exclusion

Exclusion Criteria:

  1. Other malignant tumors have been diagnosed within the previous 5 years

  2. There is distant organ metastasis (according to AJCC stage, supraclavicular lymphnode metastasis is M1, which should be excluded)

  3. Lesions invading the trachea or large blood vessels, or investigators judge thatthere is a high risk of esophageal/tracheal fistula or bleeding

  4. Have any history of active autoimmune disease or autoimmune disease

  5. Have clinical symptoms or diseases of the heart that are not under control

  6. Active infection or fever (except definite tumor fever)

  7. History or evidence of interstitial lung disease or active non-infectious pneumonia

  8. Patients with immune dysfunction and active hepatitis

  9. Those who have previously received PD-1 or PD-L1 antibody therapy

  10. Allergic to any drug in this protocol

  11. Patients receiving immunosuppressive drugs or corticosteroids >10mg/ day ofprednisone therapeutic dose within 14 days prior to enrollment

  12. Patients who had received radiotherapy, chemotherapy, targeted therapy, orimmunotherapy within 4 weeks prior to enrollment

  13. Pregnant or lactating women

Study Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: Adebrelimab: 20mg/kg day1, Q3W, 3 times
Phase: 2
Study Start date:
June 06, 2024
Estimated Completion Date:
November 30, 2026

Connect with a study center

  • Nanfang Hospital, Southern Medical University

    Guangzhou, Guangdong
    China

    Active - Recruiting

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