Status:
RECRUITING
Sintilimab and Chemotherapy Sequential Radiotherapy in Advanced Esophageal Cancer
Lead Sponsor:
Qingdao Central Hospital
Conditions:
Metastatic Esophageal Squamous Cell Carcinoma
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
PHASE3
Brief Summary
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 st...
Eligibility Criteria
Inclusion
- Diagnosed with Stage IV esophagus squamous cell carcinoma.
- Expected survival time ≥3 months
- Enrolled patients must have at least one measurable lesion conforming to the RECIST V1.1 definition.
- Physical fitness ECOG score of 0 or 1
- Organ function levels must meet the following requirements and meet the following standards:
- A) Bone marrow function: absolute neutrophil count (ANC) ≥1.5×10\^9/L, platelet count ≥90×10\^9/L, hemoglobin ≥90 g/L; B) Liver function: Total bilirubin TBIL≤1.5×ULN (total bilirubin ≤3×ULN in Subjects with Gilbert's syndrome, liver cancer or liver metastasis), AST and ALT ≤2.5×ULN in patients without liver metastasis, AST and ALT ≤5.0×ULN in patients with liver metastasis; C) Renal function: Creatinine (Cr) ≤1.5×ULN, or creatinine clearance (Ccr) ≥50 mL/min (according to Cockcroft and Gault formula); D) Urine routine / 24-hour protein quantification: qualitative urine protein ≤1+ (if qualitative urine protein ≥2+, 24 hours \< 1g can be included); E) Cardiac function: left ventricular ejection fraction ≥50%; F) Coagulation function: International standardized ratio (INR) ≤1.5×ULN, and activated partial thrombin time (APTT) ≤1.5×ULN;
Exclusion
- Known or suspected history of active autoimmune diseases, autoimmune diseases (such as interstitial pneumonia, colitis, hepatitis, pituitaritis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases or syndromes)
- Have a history of immunodeficiency, including HIV positive, or other acquired, congenital immunodeficiency disease, or history of organ transplantation and bone marrow transplantation；Interstitial lung disease, drug-induced pneumonia,requiring steroid therapy or active pneumonia with clinical symptoms or severe pulmonary dysfunction；
- There are clinical symptoms or diseases of the heart that are not well controlled, such as: (1) heart failure of NYHA class 2 or higher (2) unstable angina (3) myocardial infarction within 24 weeks (4) clinical need for treatment or Interventional supraventricular or ventricular arrhythmia；
- Have a tendency to hereditary bleeding or coagulopathy. Clinically significant bleeding symptoms or clear bleeding tendency within 3 months prior to enrollment, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, baseline fecal occult blood++ and above；
- Allergic reactions to test drugs for this application；
- Pregnant or lactating women； Those whom the investigator considered unsuitable for inclusion。
Key Trial Info
Start Date :
September 20 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2026
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT06138028
Start Date
September 20 2023
End Date
October 31 2026
Last Update
July 24 2024
Active Locations (2)
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1
Qingdao Central Hospital, Qingdao Cancer Hospital
Qingdao, Shandong, China, 266042
2
Qingdao Central Hospital
Qingdao, Shandong, China, 266042