Recurrent/metastatic esophageal squamous cell carcinoma confirmed by histology or cytology
Conditions
Interventions
Experiment group:Trifluridine/Tipiracil Tablets Combined with Anlotinib Capsules
Sponsors
Chongqing University Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Age >= 18 years at the time of enrollment; 2.ECOG performance status (PS) score: 0-1; 3.Histologically or cytologically confirmed recurrent or metastatic esophageal squamous cell carcinoma; 4.Previous treatment with fluoropyrimidine-based or taxane-based chemotherapy; 5.Received at least one standard systemic treatment regimen (combination chemotherapy + immunotherapy) after recurrence/metastasis; 6.Patients must have received immune checkpoint inhibitor therapy; 7.Expected survival >= 3 months; 8.Function of major organs meets all of the following requirements (no transfusion of any blood products or use of any cell growth factors and/or platelet-boosting drugs within 2 weeks prior to the start of study treatment): a) Hematological: i. Absolute neutrophil count (ANC) >= 1.5 × 10^9/L; ii. Hemoglobin (HB) >= 90 g/L; iii. Platelet count (PLT) >= 90 × 10^9/L; b) Hepatic function: i. AST, ALT, and ALP = 30 g/L; c) Renal function: i. Calculated creatinine clearance (CrCl) >= 60 mL/min (calculated using Cockcroft-Gault formula) or serum creatinine <= 1.5 × ULN; d) Coagulation function: i. International normalized ratio (INR), activated partial thromboplastin time (APTT), and prothrombin time (PT) <= 1.5 × ULN; 9.Female subjects of childbearing potential (theoretically aged 15–49 years, including unmarried, married, or widowed), must have a negative serum pregnancy test within 3 days before the first dose of the study drug; female subjects of childbearing potential must use an acceptable contraceptive method from the time of screening and agree to continue its use for at least 6 months after the last dose of the study drug; male subjects who are not sterilized must use an acceptable contraceptive method from screening to at least 6 months after the last dose of the study drug; the specific cessation of contraception should be determined by the investigator; 10.The subject voluntarily joins the study, is capable of complying with treatment, regular assessments, follow-up, and other study-related requirements, and signs the informed consent form;
Exclusion criteria
Exclusion criteria: 1.Presence of components other than esophageal squamous carcinoma in the tissue or cytological pathology. 2.History of allergy to the study drug or its components; 3.Except for diagnosed esophageal squamous carcinoma, the subject has had other types of malignant tumors within 5 years prior to the first dose, including tumors that were cured with adequate treatment, such as basal cell carcinoma or squamous cell carcinoma of the skin, breast carcinoma in situ, and other in situ carcinomas. 4.Use of Chinese herbal medicine or traditional Chinese medicine with anti-tumor indications within 1 week prior to enrollment; 5.Enrollment in another clinical study concurrently; 6.Patients with poorly controlled blood pressure (systolic blood pressure >= 150 mmHg, diastolic blood pressure >= 100 mmHg). 7.The subject has poorly controlled underlying diseases prior to enrollment, such as coronary artery disease, heart failure, cerebrovascular accident, hypertension, chronic obstructive pulmonary disease, interstitial lung disease, rheumatic diseases, gastrointestinal ulcers, etc. (as determined by the investigator). 8.Presence of tracheoesophageal fistula, deep esophageal ulcers, esophageal perforation, or evidence of hematemesis. 9.Untreated active hepatitis B (HBsAg positive and HBV-DNA > 1000 copies/ml (200 IU/ml) or above the detection limit) patients, who are required to receive antiviral therapy for hepatitis B during the study treatment; active hepatitis C (HCV antibody positive and HCV-RNA level above the detection limit) patients. 10.History of immunodeficiency, including HIV-positive status or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation. 11.Severe infection within 4 weeks prior to the first dose, including but not limited to infections associated with complications requiring hospitalization, sepsis, or severe pneumonia; active infections that required systemic anti-infection therapy (excluding antiviral therapy for hepatitis B or C) within 2 weeks prior to the first dose. 12.Urinary protein >= ++ in routine urine examination; 13.Presence of psychiatric or social conditions that restrict the subject's adherence to study requirements or affect the subject's ability to provide written informed consent. 14.Any arterial thromboembolic event, grade 3 or higher venous thromboembolic event, transient ischemic attack, cerebrovascular accident, hypertensive crisis, or hypertensive encephalopathy within 6 months prior to the first dose. 15.History of severe bleeding tendencies or coagulation disorders; presence of significant active bleeding within 1 month prior to the first dose (as determined by the investigator). 16.History of drug abuse, alcoholism, or substance abuse. 17.Pregnant or breastfeeding women. 18.Any past or current disease, treatment, or laboratory abnormality that could confuse the study results, affect the subject's full participation in the study, or where participation may not be in the subject's best interest.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety;OS;ORR; | — |
Countries
China
Contacts
Public ContactYan Luo
Chongqing University Cancer Hospital
Outcome results
None listed