esophageal cancer
Conditions
Interventions
Experimental group 1:Radiotherapy combined with anlotinib and tegafur suppositories
Experimental group 2:radiotherapy combined with anlotinib
Experimental group 3:Radiotherapy combined with Tegafur suppositories
Sponsors
The Second Affiliated Hospital of Xi'an Jiaotong University
Eligibility
Sex/Gender
All
Age
65 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients with histopathologically confirmed squamous oesophageal cancer; 2. Clinical staging cT1b-T4b N0-N+, medically unresectable or refusal of surgery as judged by a multidisciplinary team consultation; 3. Have at least one measurable lesion according to the solid tumour efficacy evaluation criteria RECIST version 1.1; the measurable lesion has not received local treatment such as radiotherapy; 4. Be aged =65 years, male or female 5. Have an ECOG PS score of 0-2; expected survival = 6 months 6. Have adequate organ and bone marrow function, i.e., meet the following criteria: 1) The criteria for routine blood tests are met: a. Haemoglobin content (HB) = 90g/L (no blood transfusion within 28 days); b. Absolute neutrophil count (ANC) =1.5×109/L; c. Platelet count (PLT) =80×109/L; d. White blood cell count (WBC) = 3.5 × 109/L; 2) Biochemical tests need to meet the following criteria: a. Serum total bilirubin (TBIL) = 1.5 times the upper limit of normal (ULN); b. ALT and AST = 2.5 × ULN; c. Cr = 1.5 × ULN or creatinine clearance rate (CCr) = 60 ml/min (Cockcroft-Gault formula); 3) Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) = low limit of normal (50%); 4) Adequate coagulation function, defined as an international normalised ratio (INR) or prothrombin time (PT) =1.5 times ULN
Exclusion criteria
Exclusion criteria: 1. Those with active bleeding within 2 months, or biopsy-confirmed invasion of the tracheobronchus or tracheoesophageal fistulae 2. Those with multiple factors affecting the absorption of orally administered drugs (e.g., post-gastrointestinal resection, chronic diarrhoea and intestinal obstruction); 3. Allergy to the API and excipient components of Tegafur and Anlotinib. 4. Patients with squamous cancer of the oesophagus in whom stents have been placed in the oesophageal tube and who have been judged by the investigator to be prone to bleeding tendency 5. Patients who have been assessed by the physician to be at risk of oesophageal fistula or bleeding; 6. Patients with prior radiotherapy to the same site in the oesophagus; 7. Patients with the presence of any severe and/or uncontrolled disease, including: 1) Patients with poorly controlled blood pressure (systolic =150 mmHg or diastolic =100 mmHg); patients with class I or greater myocardial ischaemia or myocardial infarction, cardiac arrhythmias (including QT intervals =430ms) and class I cardiac insufficiency (New York Heart Association (NYHA) cardiac function classification); 2) Active or uncontrolled serious infections; 3) Liver disease such as cirrhosis, decompensated liver disease, chronic active hepatitis; 4) Poorly controlled diabetes mellitus (fasting blood glucose (FBG) > 10 mmol/L); 5) Urine routine suggesting urinary protein =++ and confirmed 24-hour urine protein quantification >1.0g; 8) Long-standing unhealed wounds or fractures; 9. Pulmonary haemorrhage with NCI CTC AE V5.0 grade >1 within 4 weeks prior to enrolment; bleeding from other sites with NCI CTC AE V5.0 grade >2 within 4 weeks prior to enrolment; and patients with a bleeding tendency (e.g., active peptic ulcers) or receiving thrombolytic or anticoagulant therapy such as warfarin, heparin, or their analogues; 10. Have undergone major surgery (craniotomy, open thoracic or open abdominal surgery) within 4 weeks prior to the first dose of the study or anticipate the need for major surgery during study treatment; 11. A history of gastrointestinal perforation and/or fistula within 6 months prior to enrolment for treatment; or a history of an arterial/venous thrombotic event, such as cerebrovascular accidents (including transient ischaemic attack), deep vein thrombosis and pulmonary embolism 12. Patients whose imaging shows that the tumour has invaded a vital vascular perimeter or who, in the judgement of the investigator, have a high probability of fatal haemorrhage due to tumour invasion of a vital vessel during the follow-up study; 13. Patients with clinically significant ascites, including any ascites detectable on physical examination, previously treated or currently requiring treatment, and those with only a small amount of ascites on imaging but asymptomatic are eligible for enrolment 14. Patients with moderate amounts of fluid in both pleural cavities, or large amounts of fluid in one side of the pleural cavity, or those who have caused respiratory dysfunction requiring drainage; 15. Known to have active tuberculosis; 16. Interstitial lung disease requiring steroid hormone therapy; 17. Uncontrolled metabolic disorders or other non-malignant neoplastic organ or systemic diseases or secondary reactions to cancer that can lead to higher medical risk and/or uncertainty in the evaluation of survival 18. Significant malnutrition, such as the need for intravenous supplemental nutritional fluids; except where malnutrit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1-year locoregional recurrence–free survival, LRFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate, ORR;Progression Free Survival, PFS;Overall Survival, OS;Disease Control Rate, DCR;Safety; | — |
Countries
China
Contacts
Public ContactMa Hongbing
The Second Affiliated Hospital of Xi'an Jiaotong University
Outcome results
None listed