esophageal cancer
Conditions
Interventions
Experiment Group:Radiotherapy combined with tegafur suppository
Sponsors
the Second Affiliated Hospital of Xi'an Jiaotong University
Eligibility
Sex/Gender
All
Age
60 Years to No maximum
Inclusion criteria
Inclusion criteria: 1: 1. Be able to provide written informed consent, and understand and agree to follow the research requirements and evaluation schedule; 2. Age: = 60 years old; 3. Patients with pathologically confirmed inoperable esophageal cancer whose clinical stage is ? A-? C; 4. Newly treated patients who have not undergone surgery in the past; 5. ECOG score: = 2 points; 6. Estimated survival time = 3 months 7. All patients should have measurable or assessable target lesions; 8. No signs of esophageal perforation; 9. The main organs function normally, that is, they meet the following standards: (1) The blood routine examination standards must meet: a. HB = 100 g/L; b. ANC=1.5 × 10^9/L c. PLT=100 × 10^9/L (2) Biochemical examination shall meet the following standards: a. TBIL50 ml/min (Cockcroft Gault formula); (3) Lung function: FEV = 1L or>50% of the predicted value; 10. Subjects volunteered to join the study and signed an informed consent form, with good compliance and cooperation in follow-up.
Exclusion criteria
Exclusion criteria: 1. Patients with pathological type and primary site that do not meet the enrollment criteria; 2. Unsuitable to receive drug chemotherapy specified in the protocol 3. Have received any previous treatment for esophageal squamous cell carcinoma; 4. Patients with evidence of fistula (esophagus / bronchus or esophagus / aorta); 5. Patients with active autoimmune disease or history of autoimmune disease. Note: Patients with the following diseases will not be excluded, Can enter the further screening: 1) controllable type 1 diabetes 2) hypothyroidism (if only with hormone replacement therapy can control) 3) controllable celiac disease 4) without systemic treatment of skin diseases (such as vitiligo, psoriasis, hair loss) 5) such as no external trigger is expected not to relapse any other disease 6. Within 2 years before the treatment have any active malignant tumor, The specific cancers under investigation in this study and the locally recurrent cancers already cured (e. g., removed basal cells or squamous cell skin cancer, Superficial bladder cancer, Except for cervical cancer or breast cancer in situ); 7. There is any condition requiring systemic treatment with corticosteroids (at a dose above 10 mg / day of prednisone or equivalent) or other immunosuppressive agents within 14 days prior to treatment. Note: Patients who have currently or previously used any of the following steroid regimens can be selected: 1) Ainephrine replacement steroids (prednisone 10mg / day or equivalent dose of similar drugs) 2) topical, ocular, intra-articular, intranasal, and inhaled corticosteroids with minimal systemic absorption.3) Prophylactic short-term (7 days) use of corticosteroids (e. g., preventing contrast allergy) or for the treatment of non-autoimmune conditions (such as delayed hair hypersensitivity caused by exposure to allergens).8. Evidence of distant organ metastasis; 9. History of interstitial lung disease, non-infectious pneumonia, or uncontrolled disease, including pulmonary fibrosis, acute lung disease, etc.; 10. severe chronic or active infection (including tuberculosis infection) requiring systemic antimicrobial agent, antifungal agent, or antiviral treatment; 11. known history of HIV infection; 12. Any major surgery that required general anesthesia within 28 days prior to treatment; 13. previous allogeneic stem cell transplantation or organ transplantation;14. Any of the following cardiovascular risk factors: 1) occurrence of cardiac chest pain within 28 days before treatment, defined as moderate pain that limits instrumental activities of daily life.2) Symptomatic pulmonary embolism within 28 days prior to treatment 3) Acute myocardial infarction within 6 months prior to treatment 4) Any history of heart failure reaching grade III or IV (Appendix 6) within 6 months prior to treatment.5) Grade 2 ventricular arrhythmias within 6 months prior to treatment; 6) cerebrovascular accident within 6 months prior to treatment; 7) uncontrolled hypertension: 160 mmHg or 100 mmHg h of systolic BP prior to treatment or 100 mmHg h) 28 days before treatment; 15. Chinese herbal or Chinese patent medicine for cancer control within 14 days before the first administration of the study drug; 16. Live vaccination within 4 weeks prior to treatment. Note: Seasonal influenza vaccines are usually inactivated vaccines and are allowed. Vaccines used in the nasal cavity are live vaccines, Not allowed; 17. Interpretation unfavorable to study drug administration or affec
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate, ORR;Progression Free Survival, PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival, OS;Disease Control Rate, DCR;Quality of Life;Safety;Tumor markers; | — |
Countries
China
Contacts
Public ContactMa Hongbing
the Second Affiliated Hospital of Xi'an Jiaotong University
Outcome results
None listed