Esophageal squamous cell carcinoma
Conditions
Interventions
treatment group:1. Initial treatment: Sintilimab+Anlotinib+TP regimen: Sintilimab 200mg d1 intravenous drip, with a treatment cycle of 3 weeks
Anlotinib: 8mg orally, taken continuously for 2 weeks and stopped for 1 week, with a treatment cycle of 3 weeks
TP regimen: liposome paclitaxel 175mg/m2 intravenous infusion (with the first two cycles of liposome paclitaxel administered at 87.5 mg/m2, d1 and d8)
Cisplatin 75mg/m2 d1 intravenous infusion, with a treatment cycle of 3 weeks
2. Maintenance therapy: Sintilimab+Anlotinib: Sintilimab 200mg d1 intravenous drip, with a treatment cycle of 3 weeks
Sponsors
Qingdao Municipal Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1)Histologically confirmed unresectable, locally advanced recurrent, or metastatic esophageal squamous cell carcinoma (excluding adenosquamous carcinoma); 2)No prior systemic treatment, or recurrence at least 6 months after (neo)adjuvant therapy/radical surgery completion; 3)According to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, at least one measurable lesion; measurable lesions should not have undergone local treatments such as radiation (lesions within previously irradiated areas, if confirmed to have progressed and meet RECIST 1.1 criteria, may also be selected as target lesions); 4)Patients aged 18 to 75 years; 5)Eastern Cooperative Oncology Group Performance Status (ECOG PS) score: 0-1; expected survival of more than 3 months; 6)Adequate organ and bone marrow function, meeting the following criteria: (1) Hematological parameters should meet the following standards: - Hemoglobin (Hb) = 90 g/L (no blood transfusion in the past 28 days); - Absolute neutrophil count (ANC) = 1.5 × 10^9/L; - Platelet count (PLT) = 100 × 10^9/L. (2) Biochemical parameters should meet the following standards: - Serum total bilirubin (TBIL) = 1.5 times the upper limit of normal (ULN); - ALT and AST = 2.5 times ULN; if there are liver metastases, ALT and AST = 5 times ULN; - Cr = 1.5 times ULN or creatinine clearance rate (CCr) = 60 ml/min (Cockcroft-Gault formula); (3) Adequate coagulation function, defined as an international normalized ratio (INR) or prothrombin time (PT) = 1.5 times ULN; 7)Reproductive-age women must use appropriate contraception from screening to 3 months after discontinuation of study treatment, and must be non-lactating. Before starting medication, a negative pregnancy test is required, or one of the following criteria must be met to demonstrate no pregnancy risk: a. Postmenopausal, defined as age greater than 50 and cessation of all exogenous hormone replacement therapy with at least 12 months of amenorrhea; b. Women under 50, if they have stopped all exogenous hormone therapy for 12 months or more, and luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels are within the laboratory postmenopausal reference range, can also be considered postmenopausal.
Exclusion criteria
Exclusion criteria: Note: Patients meeting any of the following criteria will be excluded from this study: 1)Patients with ulcerative esophageal squamous cell carcinoma; 2)Patients who have undergone esophageal or tracheal stent implantation; 3)Patients with significant tumor invasion into adjacent organs (major arteries or trachea), leading to a high risk of bleeding or perforation, or patients with established fistulas; 4)Patients with actively bleeding esophageal squamous cell carcinoma within 2 months of the primary lesion; pulmonary bleeding of NCI CTC AE grade >1 within the 4 weeks prior to enrollment; bleeding at other sites of NCI CTC AE grade >2 within the 4 weeks prior to enrollment; patients with a bleeding tendency (such as active gastrointestinal ulcers) or receiving thrombolytic or anticoagulation therapy such as warfarin, or similar treatments for liver, etc.; 5)Carriers of chronic hepatitis B or patients with active hepatitis C virus (HCV) infection with HBV DNA exceeding 500 IU/mL; 6)History of immunodeficiency diseases, including HIV-positive testing or other acquired, congenital immunodeficiency diseases; 7)Presence of any active autoimmune disease or a history of autoimmune diseases (including but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism), or known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation, or other patients assessed by the investigator as having an impact on the study treatment; 8)Known symptomatic central nervous system metastases and/or carcinomatous meningitis; 9)History of other primary malignant tumors, except for: ? completely remitted malignant tumors for at least 2 years before enrollment and no need for other treatments during the study period; ? adequately treated and no evidence of disease recurrence in non-melanoma skin cancer or malignant nevus; ? adequately treated and no evidence of disease recurrence in situ carcinoma; 10)Patients with any severe and/or uncontrolled diseases, including: ? Patients using antihypertensive medications with uncontrolled blood pressure (systolic blood pressure =150 mmHg or diastolic blood pressure =100 mmHg); patients with grade II or above myocardial ischemia or myocardial infarction, arrhythmias (including QT interval =480 ms); according to NYHA standards, patients with III-IV stage heart failure, or echocardiography suggesting left ventricular ejection fraction (LVEF) 10 mmol/L); ? Urinalysis indicating urinary protein =++, and confirmed 24-hour urinary protein quantification >1.0 g; 11)Patients who have used high-dose corticosteroids or other immunosuppressive agents within 4 weeks; 12)Patients who have undergone major surgery (craniotomy, thoracotomy, or laparotomy) within the 4 weeks prior to the first dose of the study, or are expected to undergo major surgery during the study treatment period. 13)Patients with a history of gastrointestinal perforation and/or fistula within 6 months before enrollment in the treatment, or experiencing thromboembolic events such as cerebrovascular accidents (including transient ischemic attacks), deep vein thrombosis, and pulmonary embolism; 14)Clinically significant ascite
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate, ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival;Disease control rate;Safety; | — |
Countries
China
Contacts
Public ContactXiaomei Xu
Qingdao Municipal Hospital
Outcome results
None listed