Esophageal Squamous Cell Carcinoma
Conditions
Interventions
Experimental group:Toripalimab: intravenous infusion, once every 3 weeks, at a dose of 240 mg
3 cycles in total
Chemotherapy: on the day of treatment, docetaxel + cisplatin + 5-FU (DCF) Q3W regimen chemotherapy, cisplatin 70 mg/m2 ivgtt d1, docetaxel 70 mg/m2 ivgtt d1, 5-FU 750 mg/m2 ivgtt d1-5, q21d were admin
Sponsors
Fujian Provincial Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. aged 18 to 75 years, male or female; 2. pathologically confirmed operable esophageal squamous cell carcinoma, pathological stage IB/II/III patients; 3. no previous systemic anti-tumor treatment for esophageal squamous cell carcinoma; 4. no serious heart, brain, liver, lung, kidney and other vital organ dysfunction, no serious concomitant diseases, physical condition can tolerate chemoradiotherapy and surgery. 5. ECOG PS: 0-1; 6. Expected survival = 6 months; 7. Normal main organ function, blood routine, blood biochemistry and coagulation function tests; 8. Immune parameters are basically normal; 9. Women of childbearing age must have taken reliable contraceptive measures or performed pregnancy tests (serum or urine) within 7 days before enrollment, and the results are negative, and are willing to use appropriate methods of contraception during the trial and 8 weeks after the last dose of the trial drug. Men must agree to use appropriate methods of contraception or have been surgically sterilized during the trial and for 8 weeks after the last dose of trial drug; 10. the subject voluntarily joined the study and signed an informed consent form, with good compliance and cooperation in follow-up.
Exclusion criteria
Exclusion criteria: 1. esophageal squamous cell carcinoma patients with active bleeding within 2 months of the primary lesion; 2. the primary lesion was surgically removed; 3. the tumor has the possibility of invading the bronchi or great vessels, and patients with bleeding tendency. 4. failed treatment with anti-tumor angiogenic drugs; 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. known or suspected active autoimmune diseases, history of autoimmune diseases (such as interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases or syndromes); 8. history of immunodeficiency, including HIV test positive, or suffering from other acquired, congenital immunodeficiency diseases, or history of organ transplantation and allogeneic bone marrow transplantation; 9. interstitial lung disease, drug-induced pneumonia, radiation pneumonitis requiring steroid therapy or active pneumonia with clinical symptoms or severe pulmonary dysfunction; 10.Subjects with cardiovascular clinical symptoms or diseases that are not well controlled, including but not limited to: (1) NYHA class II or higher heart failure (2) unstable angina pectoris (3) myocardial infarction within 1 year (4) clinically significant supraventricular or ventricular arrhythmia that remains poorly controlled without or after clinical intervention; 11.Subjects with active hepatitis B (HBV DNA = 2000 IU/mL or 104 copies/mL), hepatitis C (hepatitis C antibody positive and HCV-RNA above the lower limit of detection of the assay); 12.Hereditary bleeding tendency or coagulopathy.Clinically significant bleeding symptoms or definite bleeding tendency within 3 months prior to enrollment, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, baseline fecal occult blood + + and above; 13.Prior anticancer treatment toxicities not recovered to CTCAE Grade 1 or less (except alopecia) or the levels specified in the inclusion/exclusion criteria; 14.Known or suspected hypersensitivity to the investigational product; 15.Pregnant or lactating women; 16.Patients considered unsuitable for inclusion by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathologic complete response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival;ORR;R0 resection rate;safety; | — |
Countries
China
Contacts
Public ContactXiaojie Pan
Fujian Provincial Hospital
Outcome results
None listed