Adebrelimab with neoadjuvant chemoradiotherapy for esophageal squamous cell carcinoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 2 trial investigates the safety and efficacy of adding adebrelimab, an immune checkpoint inhibitor, to a neoadjuvant regimen of nab-paclitaxel, carboplatin, and short-course radiotherapy in patients with resectable esophageal squamous cell carcinoma. Eligible participants have confirmed ESCC, no distant metastasis, adequate organ function, and good performance status. The goal is to see if this combination increases pathological complete response rates and improves surgical and survival outcomes compared with historical controls. Outcomes of interest include safety, pCR rate, disease-free survival, and overall survival. The study is conducted at Sun Yat-Sen Memorial Hospital with collaboration from Jiangsu HengRui Medicine Co., Ltd.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* \- 1. Provided informed consent and sign the informed consent form;
* 2\. Male or female, Aged 18-75 years (counted on the date of signing informed consent);
* 3\. Pathological confirmed ESCC;
* 4\. Patients assessed by thoracic oncologists as resectable without distant metastasis
* 5\. Patients evaluate with clinical staging of T1-4aN1-3M0 or T3-4aN0M0(AJCC 9.0) based on imaging and pathological examination results;
* 6\. Have at least one assessable lesion according to the RECIST V1.1
* 7\. ECOG-PS score: 0-1;
* 8\. Patients with normal function of organs such as heart, brain, lungs, and kidneys who can tolerate surgery;
* 9\. With a life expectancy of ≥ 6 weeks;
* 10\. Adequate major organ function without severe hematologic, cardiac, pulmonary, hepatic, renal, or bone marrow dysfunction, and no immunodeficiency disease;

Exclusion Criteria:

* 1\. Patients who have received or are currently receiving chemotherapy, radiotherapy, immunotherapy, or targeted therapy
* 2\. Patients with distant metastasis or inability to undergo resection after evaluation by thoracic surgeons
* 3\. Simultaneously developing tumors in other parts of the body
* 4\. Severe impairment of heart, liver, and kidney function (heart function grade 3-4, ALT and/or AST exceeding the upper limit of normal by more than 1.5 times, Cr (serum creatinine) exceeding the upper limit of normal by more than 1.5 times)
* 5\. Patients with a history of autoimmune diseases who were receiving immunosuppressive therapy prior to enrollment, with immunosuppressive doses\>10 mg/day or oral prednisone for more than 2 weeks
* 6\. Severe allergy to immune preparations
* 7\. Abnormal coagulation function: (PT\>16s, APTT\>53s, TT\>21s, Fib\<1.5 g/L), bleeding tendency or during thrombolytic or anticoagulant therapy
* 8\. Pregnancy or lactation period
* 9\. Other situations as judged by investigators not suitable for inclusion.;

Where it's running

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Study coordinator: Baisheng Chen, M.D, PhD
• Email: Pason06213367@163.com
• Phone: +86-13560471611

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• HS-20093 with Adebrelimab vs HS-20093 alone in advanced non-squamous NSCLC

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.