Esophageal squamous cell carcinoma
Conditions
Interventions
case series:Anlotinib and tigio
Sponsors
Fujian Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Sign a written informed consent form and voluntarily join the study; 2. Diagnosis of esophageal squamous cell carcinoma by histopathological and/or immunohistochemical examination, PD-L1 expression level CPS<10; UICC/AJCC TNM staging (8th edition 2017) is cT4N0-2M0, T2-3N0-3M0 unresectable or inoperable stage III or IVa patients; 3. Patients with locally advanced esophageal cancer after receiving radical synchronous or sequential chemoradiotherapy; 4. Age 18-75 years old; 5.ECOG PS 0-2 6. Have not previously received systemic anti-tumor therapy for esophageal cancer patients other than radiotherapy and chemotherapy, including targeted, immunotherapy, etc. 7. Have at least one measurable lesion. 8. The function of the main organs is normal, including:blood routine examination, biochemical and coagulation function and other tests are basically normal. 9. Good subject compliance and follow-up
Exclusion criteria
Exclusion criteria: 1. There is uncontrollable pleural effusion, pericardial effusion or ascites that requires repeated drainage; 2. Poor nutritional status, BMI 200ml/day); 4. Previous allergy to monoclonal antibodies, any component of anlotinib, fluorouracil or fluorouracil derivatives; 5. Have received or are receiving any of the following treatments in the past: a) Any molecularly targeted drugs such as VEGFR and EGFR or related drugs such as small molecule tyrosine kinase inhibitors against tumors; b) immunosuppressive drugs, or systemic hormonal therapy, to achieve immunosuppressive intent (dose> 10 mg/day prednisone or equivalent) within 2 weeks prior to first study use; In the absence of active autoimmune diseases, inhaled or topical steroids and adrenocorticosteroid replacement at a dose > 10 mg / day or an equivalent dose of adrenocorticosteroids are allowed; c) Have received live attenuated vaccine within 4 weeks prior to first study drug use; d) have undergone major surgery or severe trauma within 4 weeks prior to the first use of the study drug; 6. Have any active autoimmune disease or history of autoimmune disease, including but not limited to: interstitial pneumonia, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism (may be considered for inclusion after hormone replacement therapy); Patients with psoriasis or complete remission of childhood asthma/allergies who do not require any intervention in adulthood may be considered, but patients requiring medical intervention with bronchodilators are excluded; 7. Have a history of immunodeficiency or organ transplantation or allogeneic bone marrow transplantation; 8. Presence of cardiac clinical symptoms or diseases that are not well controlled, including but not limited to: Such as (1) NYHA grade II or above heart failure; (2) unstable angina; (3) Myocardial infarction occurred within 1 year; (4) clinically significant supraventricular or ventricular arrhythmias are not well controlled without clinical intervention or after clinical intervention; 9. Severe infection within 4 weeks prior to first study drug use; Baseline chest imaging suggests active lung inflammation, signs and symptoms of infection in the 14 days prior to first study use, or the need for oral or intravenous antibiotic therapy, except for prophylactic antibiotics; 10. Those who have active tuberculosis infection found by medical history or CT examination, or have a history of active tuberculosis infection within 1 year before enrollment, or have a history of active tuberculosis infection more than 1 year ago but have not been formally treated; 11. Presence of active hepatitis B, hepatitis C, 12. As judged by the investigator, there are other factors that may lead to forced termination of the study, such as having other serious diseases (including psychiatric diseases) requiring combined treatment, alcoholism, drug abuse, family or social factors, and factors that may affect the safety or compliance of subjects.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR);Progression-free survival (PFS);safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| Dysphagia relief rate;Overall survival(OS);quality of life; | — |
Countries
China
Contacts
Public ContactMingQiu Chen
Fujian Cancer Hospital
Outcome results
None listed