Esophageal Squamous Cell Carcinoma
Conditions
Interventions
immunotherapy:Camrelizumab,Apatinib and Nab-paclitaxel Plus Nedaplatin
Sponsors
National Cancer Center/ National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-75 years, male or female; 2. Patients must have histologically confirmed esophageal squamous cell carcinoma with resectable disease of primary tumor in thoracic esophagus (cT1N2, cT2-3N0-2); 3. Without prior treatments including surgery, chemotherapy, radiotherapy, and targeting treatment; 4. ECOG performance status 0-1; 5. Measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1and suitable for operation; 6. Life expectancy >12 weeks; 7. Adequate organ function as follows: (1) Hemoglobin = 90 g/L; (2) Leukocytes = 3.0×10^9/L; (3) Absolute neutrophil count (ANC) = 1.5×10^9/L; (4) Platelet count = 100×10^9/L; (5) SCr =1.5×upper limit of norm al (ULN) or creatine clearance rate: =50 mL/min; (6) Bilirubin (total) =1.5×upper limit of normal (ULN); (7) AST(SGOT) and ALT(SGPT) = 2.5 times the upper limit of normal; (8) Urine protein < 2+and if urine protein = 2 +24-hour urine protein quantitation shows that protein must be =1g; 8. Normal coagulation function, no active bleeding and thrombosis: (1) INR = 1.5×upper limit of norm al (ULN); (2) PT and APTT = 1.5×upper limit of norm al (ULN); 9. Subjects must have adequate lung function to permit surgical resection determined by pre-enrollment pulmonary function tests; 10. For females of child bearing potential, a negative serum pregnancy test result within 7d before study treatment. For female and male participants of reproductive potential must be willing to use adequate contraception for the course of the study until 2 months after the last dose of any of the drugs in the study; 11. Willing and able to provide written informed consent. 12. Patients must be with good compliance and agree to accept follow-up of disease progression and adverse events of the study
Exclusion criteria
Exclusion criteria: 1. Patients who have or are currently undergoing additional chemotherapy, radiation therapy, targeted therapy or immunotherapy; 2. Subjects with any active autoimmune disease or history of autoimmune disease(interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism); asthma in childhood has been completely relieved and can be included in adults without any intervention or vitiligo, while subjects who require medical intervention with bronchodilators are not included; 3. Known positive history or positive test for Human Immunodeficiency Virus or active Hepatitis B or Hepatitis C infection; 4. Concurrent medical condition requiring the use of cortisol (>10mg/day prednisone or equivalent dose) or other systematic immunosuppressive medications within 14 days before the study treatment. Except: inhalation or topical corticosteroids no more than 10 mg/day prednisone or equivalent; 5. Received a live vaccine within 4 weeks of the first dose of study medication or during study; 6. Hypertension with a blood pressure of systolic> 140 millimeter of mercury (mm Hg) and/or diastolic > 90 mm Hg that is not effectively controlled by anti-hypertensive therapy; 7. Uncontrolled clinically significant heart disease, including but not limited to the following: (1) > NYHA II congestive heart failure; (2) unstable angina; (3) myocardial infarction within the past 1 year; (4) clinically significant supraventricular arrhythmia or ventricular arrhythmia requiring treatment or intervention; 8. Has an active severe infection requiring systemic therapy prior to the first dose of trial treatment or an unexplained fever > 38.5 degree C during screening or before the first scheduled day of dosing; 9. Patients with prior allogeneic stem cell or solid organ transplantation; 10. Women who are pregnant or nursing women of childbearing age that are reluctant to take effective contraceptive measures throughout the trial period; 11. Subjects with active concurrent malignancies are excluded i.e.cancers other than NSCLC (except non melanoma skin cancers, in situ bladder, gastric, breast, colon or cervical cancers); 12. Active bra in metastasis or meningeal metastasis; 13. Known immediate or delayed hypersensitivity reaction to SHR-1210, apatinib, nab-paclitaxel, nedaplatin or their excipients; 14. Anyone to be considered not suitable for inclusion by principal investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| drug related adverse events;Non-delayed operation rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| objective response rate;pathological complete response rate;disease free survival;recurrence rate; | — |
Countries
China
Contacts
Public ContactJie He
National Cancer Center/ National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Outcome results
None listed