Squamous cell carcinoma
Conditions
Interventions
Case series:Anlotinib combined with Toripalimab injection plus neoadjuvant radiotherapy and chemotherapy
Sponsors
Fujian Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients aged 18-75 years, male and female unlimited; 2. Patients with esophageal squamous cell carcinoma confirmed by pathology (including histology or cytology), whose pathological stage is T3-4 or N +; 3. Patients who have not received systemic anti-tumor treatment for ESCC before; 4. The patients without severe dysfunction of the center of gravity, brain, liver, lung, kidney and other important organs, and without serious concomitant diseases can tolerate radiotherapy, chemotherapy and surgery; 5. ECoG PS 0-1 point; 6. Patients with expected survival >= 6 months; 7. The blood routine test, blood biochemical test and blood coagulation test were basically normal for the subjects with normal function of main organs; 8. Subjects with normal immune indexes; 9. Women of childbearing age must have taken reliable contraceptive measures or carried out pregnancy test (serum or urine) within 7 days before entering the group, and the result is negative, and they are willing to use appropriate contraceptive methods during the test and 8 weeks after the last administration of test drugs. For men, it is necessary to agree to use appropriate methods of contraception or sterilization after operation during the trial period and 8 weeks after the last administration of the test drug; 10. The subjects volunteered to join the study and signed the informed consent form. They had good compliance and cooperated with the follow-up.
Exclusion criteria
Exclusion criteria: 1. Patients with esophageal squamous cell carcinoma with active bleeding within 2 months of the primary lesion; 2. The primary lesion was removed surgically; 3. Patients with tumors that may invade bronchi or great vessels and have a tendency to bleed; 4. Anti-tumor angiogenesis Therapy wsa failure; 5. Patients with unsatisfactory blood pressure control (systolic blood pressure >=160 mmHg or diastolic blood pressure >=100 mmHg); 6. Previous systemic treatment for esophageal squamous cell carcinoma; 7. The patient has any active autoimmune disease or a history of autoimmune disease (such as the following, but not limited to: Interstitial pneumonia, colitis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism); 8. Have a history of immunodeficiency, including a positive HIV test, or have other acquired, congenital immunodeficiency diseases, or a history of organ transplantation and allogeneic bone marrow transplantation; 9. Interstitial lung disease, drug-induced pneumonia, radiation pneumonia requiring steroid therapy, or clinically active pneumonia or severe pulmonary dysfunction; 10. The subject has clinical cardiovascular symptoms or diseases that are not well controlled, including but not limited to: (1) NYHA class II or higher heart failure; (2) Unstable angina; (3) Myocardial infarction occurred within 1 year; (4) Clinically significant supraventricular or ventricular arrhythmias are still poorly controlled without or without clinical intervention; 11. Active hepatitis b (HBV-DNA >=10^4copies/ml or 2000 IU/ml) or hepatitis C (hepatitis c antibody and HCVRNA positive) and other liver diseases were all higher than the lower limit of the analysis method; 12. Have a tendency to inherit bleeding or coagulopathy. Have clinically significant bleeding symptoms or have a clear bleeding tendency within 3 months before enrollment, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, and fecal occult blood at baseline + or above; 13. Unrelieved toxic reactions higher than CTC AE level 1 due to any anti-tumor treatment; 14. Patients with allergic reaction to the test drug; 15. Pregnant or lactating women; 16. The investigator considers any patient who is not suitable for entering other factors of the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pathological Complete Response Rate;safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;DFS; | — |
Countries
China
Contacts
Public ContactJiancheng Li
Fujian Cancer Hospital
Outcome results
None listed