esophageal cancer
Conditions
Interventions
Treatment group:Slulimumab combined with TP regimen
Sponsors
The First Affiliated Hospital of Air Force Military Medical University (Xijing Hospital)
Eligibility
Sex/Gender
All
Age
18 Years to 82 Years
Inclusion criteria
Inclusion criteria: 1. Age: Patients over 18 years old with unresectable locally advanced/recurrent or metastatic esophageal squamous cell carcinoma, regardless of gender; 2. Patients with esophageal squamous cell carcinoma diagnosed by pathology; 3. Newly treated patients who have not undergone surgery in the past; 4. ECOG score: 0-1 points; 5. Expected survival time = 3 months; 6. All patients should have measurable or evaluable target lesions; 7. Able to consume a liquid diet or above; No signs of esophageal perforation; 8. For male subjects whose partners are women of childbearing age, surgical sterilization should be performed, or effective contraception methods should be agreed upon during the study period and within 3 months after the last study administration. 9. The subjects voluntarily joined this study and signed an informed consent form, with good compliance and cooperation in follow-up.
Exclusion criteria
Exclusion criteria: 1. Patients with pathological types and primary lesion locations that do not meet the inclusion criteria; 2. Those who are known to be allergic to macromolecular protein preparations, or components of sulolizumab, or to chemotherapy drugs and other allergens; 3. There is a risk of esophageal perforation or the presence of esophageal ulcers; 4. Individuals with a history of immunodeficiency, including those who test positive for HIV or have other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation; 5. Intravenous infusion is not allowed; 6. Individuals with a history of drug abuse, drug abuse, or alcohol abuse; 7. According to the researcher's judgment, there are other factors that may cause the subject to be forced to terminate the study midway, such as other serious illnesses (including mental illness) requiring concurrent treatment, severe abnormal laboratory test values, family or social factors, which may affect the safety of the subject or the collection of trial data; 8. Research center staff, researchers' partners or first degree relatives;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| R0 resection rate;Disease-free survival;Objective relief rate;Quality of life rating;Relief rate of swallowing difficulties;The incidence of grade III-IV adverse reactions; | — |
Countries
China
Contacts
Public ContactLi Xiaohua
The First Affiliated Hospital of Air Force Military Medical University (Xijing Hospital)
Outcome results
None listed