Cervical Esophageal Cancer
Conditions
Interventions
Test group:islelizumab combined with concurrent chemoradiotherapy
Sponsors
Fudan University Shanghai Cancer center
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Signed informed consent Age 18-75 years Histologically or cytologically confirmed squamous cell carcinoma of the cervical esophagus Stage (UICC/AJCC 6th) II-III (T1b-4N0-1M0) No prior systemic therapy for esophageal cancer At least one measurable lesion according to RECIST 1.1 ECOG score of 0 to 1 Adequate organ function on laboratory tests within 28 days prior to first dose: (1) Blood routine: WBC >= 3.0*10^9/L; ANC >= 1.5*10^9/L; PLT >=100*10^9/L; HGB >=80 g/L; (2) Liver function: AST = 30 mL/min; (4) Coagulation function: INR <= 1.5, APTT <= 1.5*ULN; (5) Electrocardiogram showed no significant abnormalities Male subjects and females of childbearing potential must use contraception from the start of the first dose until 3 months after the last dose of study drug
Exclusion criteria
Exclusion criteria: 1. history and complications Subjects with any known active autoimmune disease (subjects may be enrolled if they are clinically stable and do not require systemic immunosuppressants, such as type I diabetes mellitus requiring hormone therapy only and hypothyroidism, and skin diseases not requiring systemic therapy). Subjects with any complication requiring systemic treatment with corticosteroids such as prednisone (> 10 mg/day) or immunosuppressive drugs within 14 days prior to the first dose (subjects with adrenal insufficiency treated with inhaled or topical corticosteroids if no active autoimmune disease, and prednisone (> 10 mg/day) for hormone replacement therapy may be enrolled). Subjects who have received tumor vaccines or other immune-activating antineoplastic agents (eg, interferon, interleukin, thymosin, or immune cell therapy) within 1 month prior to first dose. Subject is participating in another clinical trial or has received a drug intervention from another clinical trial within 4 weeks prior to first dose. Subjects with other malignancies requiring treatment (subjects with cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma, breast carcinoma in situ or cervical carcinoma in situ who have received radical treatment and do not require other treatment can be enrolled) The subject had previous severe cardiovascular disease: myocardial ischemia or infarction above grade II, poorly controlled arrhythmia (including QTc interval >= 480 ms); cardiac insufficiency grade III-IV; left ventricular ejection fraction (LVEF) = 10^3 copies/mL) or active hepatitis C (HCV antibody positive and HCV-DNA positive, requiring antiviral therapy). 3. Allergic reactions and adverse drug reactions should be excluded; allergic or hypersensitivity to monoclonal antibodies; allergic or intolerant reactions during infusion should be excluded; diseases or laboratory abnormalities that, in the investigator 's opinion, will affect the study results, or are not in the interests of the subject should be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-year overall survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| objective response rate;overall survival;progression-free survival;safety and tolerance; | — |
Countries
China
Contacts
Public ContactZhang Junhua
Fudan University Shanghai Cancer Center
Outcome results
None listed