A Phase II Clinical Study on the Efficacy and Safety of Adebrelimab Combined With Chemoradiotherapy in Patients With Unresectable Locally Advanced or Postoperative Recurrent Esophageal Squamous Cell Carcinoma

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
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• Age 18-75 years old, gender unlimited

• Esophageal squamous cell carcinoma confirmed by histology and unresectable locally advanced or postoperative recurrence

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

• ECOG: 0\

⁃ 1

• 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 times ULN, 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

Locations
Other Locations
China
Nanfang Hospital, Southern Medical University
RECRUITING
Guangzhou
Contact Information
Primary
Wei Wang
29262574@qq.com
86+18520529179
Time Frame
Start Date: 2024-06-06
Estimated Completion Date: 2025-11-30
Participants
Target number of participants: 30
Treatments
Experimental: Adebrelimab combined with chemoradiotherapy
Related Therapeutic Areas
Sponsors
Leads: Nanfang Hospital, Southern Medical University

This content was sourced from clinicaltrials.gov