Phase
Condition
Carcinoma
Lung Cancer
Esophageal Disorders
Treatment
TP regimen (cis-platinum ; Tocetaxel ) combined with PD-1 inhibitors(Sintilimab)
Clinical Study ID
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
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 RECISTV1.1 definition.
Physical fitness ECOG score of 0 or 1
Organ function levels must meet the following requirements and meet the followingstandards:
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
Exclusion Criteria:
Known or suspected history of active autoimmune diseases, autoimmune diseases (suchas interstitial pneumonia, colitis, hepatitis, pituitaritis, vasculitis, nephritis,hyperthyroidism, hypothyroidism, including but not limited to these diseases orsyndromes)
Have a history of immunodeficiency, including HIV positive, or other acquired,congenital immunodeficiency disease, or history of organ transplantation and bonemarrow transplantation;Interstitial lung disease, drug-induced pneumonia,requiringsteroid therapy or active pneumonia with clinical symptoms or severe pulmonarydysfunction;
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 orInterventional supraventricular or ventricular arrhythmia;
Have a tendency to hereditary bleeding or coagulopathy. Clinically significantbleeding symptoms or clear bleeding tendency within 3 months prior to enrollment,such as gastrointestinal bleeding, hemorrhagic gastric ulcer, baseline fecal occultblood++ and above;
Allergic reactions to test drugs for this application;
Pregnant or lactating women; Those whom the investigator considered unsuitable forinclusion。
Study Design
Connect with a study center
Qingdao Central Hospital
Qingdao, Shandong 266042
ChinaActive - Recruiting
Qingdao Central Hospital, Qingdao Cancer Hospital
Qingdao, Shandong 266042
ChinaActive - Recruiting

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