RecruitingNCT05952661

Minimally Residual of Esophageal Cancer 001

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

Sponsor

Hebei Medical University Fourth Hospital

Enrollment

56 participants

Start Date

Feb 22, 2023

Study Type

OBSERVATIONAL

Conditions

Esophageal Carcinoma Minimal Residual Disease

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria8

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

Exclusion Criteria1

(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