Assessing minimal residual disease in esophageal cancer patients

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 trial evaluates changes in minimal residual disease (MRD) status in patients with inoperable stage II-III esophageal squamous cell cancer (ESCC) before and after treatment with radical concurrent chemoradiotherapy and immunotherapy. It aims to correlate MRD status with treatment efficacy and explore the relationship between MRD and the immune microenvironment, radiotherapy dose, and tumor recurrence. Blood and tissue samples will be collected at various time points to analyze circulating tumor DNA (ctDNA) and its mutations. The primary endpoint focuses on the relationship between MRD status and treatment outcomes, while secondary and exploratory endpoints will provide additional insights into the disease's behavior and treatment response.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. age: 18 - 75 years
2. gender: both sexes, as balanced as possible
3. patients with clinically confirmed TNM 8th stage II-III ESCC by histopathology and are not suitable for surgery
4. patients receive neoadjuvant immunochemotherapy, followed by radical CCRT combined with immunotherapy and finally adjuvant immunotherapy
5. Eastern Cooperative Oncology Group (ECOG) score: 0-1
6. the functional condition of the organ meets the following requirements- haematological indicators: absolute neutrophil count ≥ 1.5 \* 109/L, platelet count ≥ 100 \* 109/L, haemoglobin count≥ 9 g/dL; good coagulation: platelet count ≥ 100 x 109/L. Liver: total bilirubin ≤ 2 times the upper limit of normal, ghrelin and ghrelin ≤ 2.5 times the upper limit of normal. Renal: creatinine ≤ 1.5 times the upper limit of normal, or creatinine clearance ≥ 60 mL/min (calculated by the Cockcroft-Gault formula)
7. women of childbearing age must have a urine pregnancy test with a negative result within 7 days prior to starting treatment
8. patients understand and voluntarily sign the informed consent form

Exclusion Criteria:

* (1) patients have been diagnosed or treated for another malignancy within 5 years prior to the start of this study (2) adenocarcinoma, mixed adenosquamous or other pathological types of esophageal cancer (3) any unstable systemic disease, including: active infection, uncontrolled hypertension, unstable angina, angina pectoris starting within the last 3 months, congestive heart failure (≥ New York Heart Association \[NYHA\] class II), myocardial infarction (6 months prior to enrollment), severe arrhythmia requiring medication, liver, kidney or metabolic disease (4) with known or suspected active autoimmune disease (5) previous treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137 or anti-CTLA-4 antibodies or any other antibodies or drugs that specifically target T-cell co-stimulation or checkpoint pathways (6) known history of testing positive for human immunodeficiency virus (HIV) or known to have acquired immunodeficiency syndrome (AIDS) (7) female patients who are pregnant or breastfeeding (8) other conditions deemed unsuitable for enrolment by the investigator

Where it's running

• Fourth Hospital of Hebei Medical University
  Shijiazhuang, Hebei, China Recruiting

Study contacts

• Principal investigator: Wenbin Shen, PhD — Hebei Medical University Fourth Hospital
• Study coordinator: Wenbin Shen, PhD
• Email: wbshen1979@sina.com
• Phone: +86 15831183879

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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.