Adebrelizumab after surgery for esophageal squamous cell cancer.

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, randomized interventional trial tests adjuvant adebrelizumab in adults with thoracic esophageal squamous cell carcinoma who have undergone radical R0 resection 4–16 weeks prior. Eligible patients have clinical stage cT1b-2N1-3M0 or cT3-4aN0-3M0, ECOG 0–1, and adequate organ function based on standard blood and biochemical criteria. Participants are randomized to receive adjuvant adebrelizumab and are followed for safety, recurrence, and survival outcomes. The trial is conducted at Hebei Medical University Fourth Hospital in Shijiazhuang, Hebei, China.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1.Age:≥18 years old, male or female; 2.Histopathologically confirmed esophageal squamous cell cancer with initial clinical stage cT1b-2N1-3M0 or cT3-4aN0-3M0 in the thoracic esophagus; 3.Radical surgery with R0 resection 4-16 weeks prior to randomisation; 4.Eastern Cooperative Oncology Group (ECOG) performance status of 0-1; 5.Expected survival ≥ 12 months; 6.Left ventricular ejection fraction is \>50%; 7.Normal functioning of major organs, i.e. meeting the following criteria:

1. routine blood tests:

   1. HB≥90g/L；
   2. ANC≥1.5×109/L；
   3. PLT≥100×109/L；
2. biochemical examination:

   1. ALT and AST\<2.5ULN（liver metastasis: ALT and AST\<5ULN）；
   2. TBIL≤1.5ULN；
   3. creatinine ≤1.5ULN； 8.Participants were willing to join in this study, written informed consent, good adherence and co-operation with follow up.

Exclusion Criteria:

1. Patients initially diagnosed as unresectable (e.g. large metastatic lymph nodes) and treated with conversion therapy;
2. Patients with severe postoperative complications who are not suitable for adjuvant therapy;
3. Patients who have received any form of adjuvant therapy after surgery;
4. Patients who have received or are receiving other chemotherapy, radiotherapy or targeted therapy;
5. Pre-existing other malignancies, unless complete remission was achieved at least 5 years prior to enrolment and no other treatment is expected to be required during the study period;
6. Patients with active, known or suspected autoimmune disease, including but not limited to: interstitial pneumonitis, enteritis, hepatitis, pituitary gland inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism (may be considered for inclusion after hormone replacement therapy); patients with psoriasis or childhood asthma/allergies that have been in complete remission and do not require any intervention in adulthood may be considered for inclusion, but medical intervention with bronchodilator is required patients may not be included;
7. People with active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection;
8. Pregnant or breastfeeding women and women of childbearing age with a history of immunodeficiency, including HIV-positive, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation or allogeneic bone marrow transplantation who are not using contraception during the trial period;
9. Presence of clinically uncontrolled cardiac symptoms or disease, including but not limited to, such as (1) NYHA class II or higher heart failure, (2) unstable angina, (3) myocardial infarction within 6 months, (4) clinically significant supraventricular or ventricular arrhythmia not clinically intervened with or poorly controlled after clinical intervention;
10. Not suitable for enrolment in the investigator's comprehensive assessment.

Where it's running

• 12, Jiankang road, Chang'an District, Shijiazhuang, Hebei 050000, China
  Shijiazhuang, Hebei, China Recruiting

Study contacts

• Study coordinator: Ziqiang Tian
• Email: tizq12@vip.163.com
• Phone: 18531118000

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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.