Assessing minimal residual disease in esophageal cancer patients

Minimal Residual Disease Guided Radical Chemoradiotherapy Combined With Immunotherapy After Neoadjuvant Immunochemotherapy Followed by Adjuvant Immunotherapy for Esophageal Squamous Cell Cancer

This study is testing how treatment affects leftover cancer cells in patients with advanced esophageal cancer to see if it helps predict how well the treatment is working.

Quick facts

• Study type: Observational
• Enrollment: 56 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Hebei Medical University Fourth Hospital (other)
• Drugs / interventions: immunotherapy
• Locations: 1 site (Shijiazhuang, Hebei)
• Trial ID: NCT05952661 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18-75 with clinically confirmed stage II-III esophageal squamous cell cancer who are not suitable for surgery.

Not a fit: Patients with early-stage esophageal cancer or those who have already undergone surgical intervention may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve treatment strategies for patients with esophageal cancer by providing insights into MRD and its correlation with treatment efficacy.

How similar studies have performed: While this approach is novel in the context of esophageal cancer, other studies have shown success in using ctDNA for monitoring minimal residual disease in various cancers.

Eligibility criteria

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 this trial is running

Shijiazhuang, Hebei

• 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

Conditions: Esophageal Carcinoma, Minimal Residual Disease, circulating tumor DNA, ctDNA, minimal residual disease, MRD, esophageal cancer, esophageal carcinoma