Minimally Residual of Esophageal Cancer 001

Trial Title: Minimally Residual of Esophageal Cancer 001

NCT ID: NCT05952661

Condition: Esophageal Carcinoma
Minimal Residual Disease

Conditions: Official terms:
Neoplasm, Residual
Esophageal Neoplasms

Conditions: Keywords:
circulating tumor DNA
ctDNA
minimal residual disease
MRD
esophageal cancer
esophageal carcinoma
neoadjuvant immunochemotherapy
chemoradiotherapy
adjuvant immunotherapy

Study type: Observational

Overall status: Recruiting

Study design:

Time perspective: Prospective

Summary: This trial aims to assess changes in minimal residual disease (MRD) status before and after radical concurrent chemoradiotherapy combined with immunotherapy and adjuvant immunotherapy after neoadjuvant immunochemotherapy in patients with inoperable stage II-III esophageal squamous cell cancer (ESCC), and correlate with the efficacy of adjuvant immunotherapy.

Detailed description: Presence of circulating tumor DNA (ctDNA) is indicative for minimal residual disease (MRD) and has high predictive value for efficacy and tumor recurrence. Concurrent chemoradiotherapy becomes the standard of care for unresectable, locally advanced esophageal squamous cell cancer, and the addition of immunotherapy to radiotherapy has been shown to increase efficacy without increasing side effects. The ECMRD-001 trial aims to assess changes in MRD status before and after radical concurrent chemoradiotherapy combined with immunotherapy and adjuvant immunotherapy after neoadjuvant immunochemotherapy in patients with inoperable stage II-III esophageal squamous cell cancer (ESCC). The specimen collection time points were divided into MRD-related blood collections, MRD-related tissue collection, T-cell immunohistobank-related blood collections, and T-cell immunohistobank-related tissue collection before, during, and after treatment and follow-up. Primary endpoint is the relationship between MRD status at different time points and treatment efficacy. Secondary endpoints include the relationship between MRD status and immune microenvironment, radiotherapy dose, and tumor recurrence. Exploratory endpoint is to investigate ctDNA mutations in ESCC patients receiving adjuvant immunotherapy. To the investigators' knowledge, the ECMRD-001 study is the first clinical trial to investigate ctDNA-based MRD guided strategies in stage II-III ESCC patients who receive radical chemoradiotherapy combined with immunotherapy after neoadjuvant immunochemotherapy followed by adjuvant immunotherapy. After our research it may be possible to confirm that ctDNA-based MRD may be a predictive marker for the efficacy and tumor recurrence of inoperable ESCC patients; elevated ctDNA-MRD may predict tumor recurrence earlier than imaging; ctDNA-based MRD analysis and ctDNA-based MRD guided diagnosis and treatment may be implemented into clinical practice to improve efficacy and reduce tumor recurrence of inoperable stage II-III ESCC.

Criteria for eligibility:

Study pop:
Esophageal squamous cell cancer patients who receive radical chemoradiotherapy combined with immunotherapy after neoadjuvant immunochemotherapy followed by adjuvant immunotherapy.

Sampling method: Non-Probability Sample
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

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Locations:

Facility:
Name: Fourth Hospital of Hebei Medical University

Address:
City: Shijiazhuang
Zip: 050011
Country: China

Status: Recruiting

Contact:
Last name: Wenbin Shen, PhD

Phone: +86 15831183879
Email: wbshen1979@sina.com

Contact backup:
Last name: Hesong Wang, PhD

Phone: +86 18810775196
Email: wanghesongmz@163.com

Start date: February 22, 2023

Completion date: December 31, 2027

Lead sponsor:
Agency: Hebei Medical University Fourth Hospital
Agency class: Other

Source: Hebei Medical University Fourth Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05952661