Esophageal Squamous Cell Carcinoma
Conditions
Interventions
Experimental group:neoadjuvant: camrelizumab+apatinib, adjuvant: camrelizumab
Sponsors
Sichuan Cancer Hospital
Eligibility
Sex/Gender
All
Age
70 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. The patients voluntarily joined the study, signed the informed consent, and cooperated with the follow-up; 2. Locally advanced resectable thoracic esophageal carcinoma was evaluated by CT/MRI/EUS with clinical stage of cT1b-3N0-2M0 (according to AJCC 8th Edition); 3. Patients aged >=70 years or who do not want to receive chemotherapy, no gender limit; 4. R0 excision is expected; 5. Plan to receive surgical treatment after the completion of neoadjuvant therapy; 6. No contraindications were found in preoperative organ function tests; 7. ECOG PS: 0 ~ 1 score; 8. Vital organ functions meet the following requirements (no blood components and cell growth factors are allowed to be used 2 weeks before the study treatment) : (1) Blood routine examination must meet: neutrophil absolute count (ANC) >=1.5x10^9/L; Hemoglobin (HB) >=9g/dL; Platelet (PLT) >=100x10^9/L; Serum albumin (ALB) >=2.8g/dL; (2) Biochemical examination must meet: total bilirubin (TBIL) =50ml/min (Cockcroft-Gault formula); Thyroid function is normal; 9. Expected survival >=3 months; 10. The investigators determined that patients could receive carrilizumab combined with Apatinib; 11. The patient has no autoimmune disease; 12. The patient had not received antitumor therapy before; 13. Fertile female patients should undergo a urine or serum pregnancy test that proves negative within 72 hours prior to receiving the first study drug administration and be willing to use effective methods of contraception between the trial period and 3 months after the last carrilizumab administration; Male patients with a partner of a woman of childbearing age should use effective contraception during the trial period and within 3 months after the last carrilizumab administration; 14. The patients have good compliance and cooperate with follow-up visits.
Exclusion criteria
Exclusion criteria: 1. The tumor obviously invaded the organs adjacent to the esophageal lesion (major artery or trachea); 2. Patients with supraclavicular lymph node metastasis; 3. Uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated drainage; 4. Poor nutritional status, BMI =140 mmHg or diastolic blood pressure >=90 mmHg); 9. Congenital or acquired immune deficiency (such as HIV infection), active hepatitis B (HBV-DNA>=10^4 copy number /mL) or hepatitis C (HCV antibody positive and HCV-RNA higher than the lower limit of assay); 10. Patients with abnormal coagulation function (INR>2.0, PT>16s), bleeding tendency or receiving thrombolytic or anticoagulant therapy are allowed to use low-dose aspirin and low molecular weight heparin prophylactically; 11. Patients requiring systemic treatment with corticosteroids (> 10mg/ day, prednisone therapeutic dose) or other immunosuppressant within 14 days prior to initial use of the study drug; In the absence of active autoimmune disease, inhaled or topical steroid and prednisone therapeutic dose of adrenocortical hormone replacement at doses > 10mg/ day are permitted; 12. Obvious blood coughing or daily hemoptysis of 2.5ml or above within 2 months before enrollment; 13. Had clinically significant bleeding symptoms or definite bleeding tendency within 3 months before randomization; 14. Urine routine indicated urinary protein >= ++ and 24-hour urinary protein content was confirmed to be >1.0 g; 15. The patient had an active infection, unexplained fever >=38.5? within 7 days prior to medication, or leukocyte count >15x10^9/L at baseline; 16. In the investigator's judgment, the patients had other factors that might have led to their being forced to terminate the study, such as other serious medical conditions (including mental illness) requiring concomitant treatment, serious abnormalities in laboratory tests, family or social factors, and difficulty in long-term follow-up; 17. The researchers determined that other conditions were not suitable for inclusion in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety;Event-free survival;Disease-free survival;Overall survival;R0 resection rate;Neoadjuvant therapy completion rate; | — |
Countries
China
Contacts
Public ContactLeng Xuefeng
Sichuan Cancer Hospital
Outcome results
None listed