Minimally Residual of Esophageal Cancer 001

NCT05952661 | Recruiting DMC

• 1 other identifier: ECMRD-001
• Study Type: observational
• Target: 56
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Esophageal Carcinoma; Minimal Residual Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Correlations of minimal residual disease (MRD) and efficacy

  The changes in MRD status before and after radical CCRT combined with immunotherapy and adjuvant immunochemotherapy in patients with inoperable resectable stage II-III ESCC, correlating with the efficacy of adjuvant immunotherapy

  2023/2/22-2027/12/31

Secondary Outcomes (5)

• The differences in the efficacy of neoadjuvant immunochemotherapy in patients with positive versus negative blood MRD prior to radical concurrent chemoradiotherapy (CCRT) combined with immunotherapy following neoadjuvant immunochemotherapy

  2023/2/22-2027/12/31

• The differences in the immune microenvironment in patients with different efficacy responses after radical CCRT combined with immunotherapy

  2023/2/22-2027/12/31

• The differences in MRD status between radiation doses of 50Gy and 60Gy, and the correlation with patient prognosis

  2023/2/22-2027/12/31

• The association between serial changes in MRD status and the efficacy of adjuvant immunotherapy

  2023/2/22-2027/12/31

• The timing of MRD advance warning of recurrence in patients ahead of imaging cues

  2023/2/22-2027/12/31

Other Outcomes (1)

• ctDNA mutation profiles in ESCC patients undergoing adjuvant immunotherapy.

  2023/2/22-2027/12/31

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• age: 18 - 75 years
• gender: both sexes, as balanced as possible
• patients with clinically confirmed TNM 8th stage II-III ESCC by histopathology and are not suitable for surgery
• patients receive neoadjuvant immunochemotherapy, followed by radical CCRT combined with immunotherapy and finally adjuvant immunotherapy
• Eastern Cooperative Oncology Group (ECOG) score: 0-1
• 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)
• women of childbearing age must have a urine pregnancy test with a negative result within 7 days prior to starting treatment
• patients understand and voluntarily sign the informed consent form

You may not qualify if:

• (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

Sponsors & Collaborators

• Hebei Medical University Fourth Hospital: lead

Study Sites (1)

Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050011, China

RECRUITING

Related Publications (1)

• Wang H, Zhang X, Zhao X, Song C, Deng W, Shen W. Minimal residual disease guided radical chemoradiotherapy combined with immunotherapy after neoadjuvant immunochemotherapy followed by adjuvant immunotherapy for esophageal squamous cell cancer (ECMRD-001): a study protocol for a prospective cohort study. Front Immunol. 2024 Jan 11;14:1330928. doi: 10.3389/fimmu.2023.1330928. eCollection 2023.

  PMID: 38274807 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

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. The investigators will test circulating tumor DNA (ct-DNA) based minimal residual disease (MRD) indicators for research

MeSH Terms

Conditions

Esophageal Neoplasms; Neoplasm, Residual

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Wenbin Shen, PhD

  Hebei Medical University Fourth Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wenbin Shen, PhD

CONTACT

+86 15831183879; wbshen1979@sina.com

Hesong Wang, PhD

CONTACT

+86 18810775196; wanghesongmz@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2023
• First Posted: July 19, 2023
• Study Start: February 22, 2023
• Primary Completion: December 31, 2024
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 19, 2023

Record last verified: 2023-06

Locations

CN (1)