Actively Recruiting
Minimally Residual of Esophageal Cancer 001
Led by Hebei Medical University Fourth Hospital · Updated on 2023-07-19
56
Participants Needed
1
Research Sites
253 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Minimally Residual of Esophageal Cancer 001
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years
- Both sexes, aiming for balanced gender representation
- Clinically confirmed stage II-III esophageal squamous cell cancer (ESCC) by histopathology, not suitable for surgery
- Patients have received neoadjuvant immunochemotherapy, followed by radical concurrent chemoradiotherapy combined with immunotherapy, and then adjuvant immunotherapy
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate organ function as shown by blood tests: absolute neutrophil count at least 1.5 x 10^9/L, platelet count at least 100 x 10^9/L, hemoglobin at least 9 g/dL; liver tests no more than twice the upper normal limit; kidney function with creatinine no more than 1.5 times the upper normal limit or creatinine clearance at least 60 mL/min
- Women of childbearing age must have a negative urine pregnancy test within 7 days before starting treatment
- Patients must understand the study and voluntarily sign informed consent
You will not qualify if you...
- Diagnosis or treatment for another cancer within 5 years before the study
- Esophageal cancer types other than squamous cell carcinoma, such as adenocarcinoma or mixed adenosquamous
- Unstable systemic diseases including active infection, uncontrolled high blood pressure, recent angina, heart failure (class II or higher), recent heart attack, severe arrhythmia requiring medication, or liver, kidney, or metabolic diseases
- Known or suspected active autoimmune diseases
- Previous treatment with certain immune checkpoint or T-cell targeting antibodies
- Known HIV infection or AIDS
- Pregnant or breastfeeding women
- Any other condition that the investigator considers unsuitable for the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China, 050011
Actively Recruiting
Research Team
W
Wenbin Shen, PhD
CONTACT
H
Hesong Wang, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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