Actively Recruiting
Sintilimab and Chemotherapy Sequential Radiotherapy in Advanced Esophageal Cancer
Led by Qingdao Central Hospital · Updated on 2024-07-24
90
Participants Needed
2
Research Sites
162 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is an investigator-initiated, single-arm, exploratory clinical study.The study population consisted of treatment naive advanced esophageal squamous cell carcinoma patients. The purpose of this study was to evaluate the efficacy and safety of immunotherapy combined with chemotherapy and residual lesions irradiation of esophageal squamous cell carcinoma.
CONDITIONS
Official Title
Sintilimab and Chemotherapy Sequential Radiotherapy in Advanced Esophageal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with stage IV esophageal squamous cell carcinoma
- Expected to live at least 3 months
- Have at least one measurable lesion according to RECIST V1.1
- Physical health status with ECOG score 0 or 1
- Adequate bone marrow function with ANC ≥1.5×10^9/L, platelets ≥90×10^9/L, hemoglobin ≥90 g/L
- Liver function with total bilirubin ≤1.5×ULN (≤3×ULN for Gilbert's syndrome or liver metastasis), AST and ALT ≤2.5×ULN without liver metastasis or ≤5.0×ULN with liver metastasis
- Kidney function with creatinine ≤1.5×ULN or creatinine clearance ≥50 mL/min
- Urine protein ≤1+ qualitatively; if ≥2+, 24-hour urine protein less than 1g
- Cardiac function with left ventricular ejection fraction ≥50%
- Coagulation function with INR and APTT ≤1.5×ULN
You will not qualify if you...
- History or suspicion of active autoimmune diseases (including interstitial pneumonia, colitis, hepatitis, pituitaritis, vasculitis, nephritis, hyperthyroidism, hypothyroidism)
- History of immunodeficiency including HIV positive, congenital or acquired immunodeficiency, organ or bone marrow transplantation
- Interstitial lung disease, drug-induced pneumonia, or active pneumonia requiring steroid therapy or with severe lung dysfunction
- Poorly controlled heart conditions such as NYHA class 2 or higher heart failure, unstable angina, recent myocardial infarction within 24 weeks, or arrhythmia requiring treatment
- Known bleeding disorders or recent significant bleeding within 3 months including gastrointestinal bleeding or hemorrhagic gastric ulcer
- Allergic reactions to the study drugs
- Pregnant or breastfeeding women
- Any condition deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Qingdao Central Hospital, Qingdao Cancer Hospital
Qingdao, Shandong, China, 266042
Actively Recruiting
2
Qingdao Central Hospital
Qingdao, Shandong, China, 266042
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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