RecruitingPhase 2NCT06885814

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

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


Sponsor

Nanfang Hospital, Southern Medical University

Enrollment

30 participants

Start Date

Jun 6, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing adebrelimab — a checkpoint immunotherapy drug — combined with chemoradiotherapy (chemotherapy plus radiation given together) for people with esophageal squamous cell carcinoma (a type of esophageal cancer) that cannot be removed with surgery or has come back after surgery. **You may be eligible if...** - You are between 18 and 75 years old - You have esophageal squamous cell carcinoma that is locally advanced and cannot be surgically removed, or has recurred after surgery - Your cancer has at least one measurable lesion that has not previously been radiated - You are in good overall health (ECOG 0 or 1) - Your expected survival is at least 12 weeks - Your blood counts and organ function are within acceptable ranges **You may NOT be eligible if...** - You have been diagnosed with another cancer within the past 5 years - Your cancer has spread to distant organs - Your tumor invades the windpipe or major blood vessels - You have active autoimmune disease or uncontrolled heart disease - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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

Concurrent Chemoradiotherapy combined with Immunotherapy,including: Radiotherapy: intensity modulated radiotherapy, PGTV 50-50.4Gy/25-28F, 1.8-2Gy/F, 5 times a week; Chemotherapy: paclitaxel 50mg/ m2 + cisplatin 25mg/ m2, intravenous infusion of day1, once a week, a total of 5 times; Adebrelimab: 20mg/kg day1, Q3W, 3 times.


Locations(1)

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China

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NCT06885814


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