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NCT05952661Recruiting

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

Source: ClinicalTrials.gov · Last updated 19 Jul 2023 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
56 (estimated)
First submitted
20 Jun 2023
Start date
22 Feb 2023
Primary completion date
31 Dec 2024
Lead sponsor
Hebei Medical University Fourth Hospital
NCT number
NCT05952661

What you commit to

  • Study type: Observational
  • Planned participants: 56
  • From 22 Feb 2023 to the primary completion date, 31 Dec 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • (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

Who the study is looking for

  • 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

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Fourth Hospital of Hebei Medical University
Coordinator of this site? Confirm its status
ShijiazhuangChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.