Esophageal carcinoma
Conditions
Interventions
Cohort A: Unresectable Esophageal Squamous Cell Carcinoma:Sintilimab 200mg (for subjects with a baseline body weight <50kg, a dose of 3mg/kg is used) is administered each time by intravenous infusion
Sponsors
The First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-80 years old, male and female. 2. Patients with unresectable esophageal squamous cell carcinoma (limited to cT4b or giant lymph nodes). 3. ECOG performance status: 0 - 1. 4. Expected survival >= 12 weeks. 5. The main organ function is normal, which meets the following criteria: (1) Blood routine examination: 1) HB >= 90 g/L; 2) ANC >= 1.5x10^9/L; 3) PLT >= 80x10^9/L. (2) Biochemical examination: 1) ALB >= 30 g/L; 2) ALT and AST = 60 ml/min. 6. Doppler ultrasound evaluation: left ventricular ejection fraction (LVEF) >= the lower limit of normal (50%). 7. Female subjects of childbearing potential must agree to use effective contraception (e.g., IUDs, contraceptives, or condoms) during the study and for 6 months after study completion, have a negative serum or urine pregnancy test within 7 days prior to enrollment, and must not be breastfeeding. 8. Male subjects must consent to use effective contraception during the study and for 6 months after study completion. 9. Subjects voluntarily join the study, sign the informed consent form, have good compliance, and agree to cooperate with follow-up. ,.
Exclusion criteria
Exclusion criteria: 1.Do not meet the aforementioned inclusion criteria. 2.History of allergy or metabolic disorder to paclitaxel and platinum-based drugs. 3.Patients with brain metastases. 4.Patients with any active autoimmune disease or a history of autoimmune diseases (including, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism; patients with vitiligo may be included; childhood asthma that has completely resolved in adulthood without any intervention may be included; asthma requiring medical intervention with bronchodilators cannot be included). 5.Patients who are using immunosuppressants or systemic hormonal therapy for immunosuppressive purposes (dose >10mg/day prednisone or equivalent) and continued use within 2 weeks prior to enrollment. 6.Patients with any severe and/or uncontrolled diseases, including: patients with poorly controlled blood pressure (systolic pressure >=150mmHg or diastolic pressure >=100 mmHg); patients with myocardial ischemia or myocardial infarction above grade I, arrhythmia (including QT interval >=480ms), and cardiac insufficiency grade I. 7.Active or uncontrolled severe infection. 8.Liver diseases such as decompensated liver disease, active hepatitis B (HBV-DNA >=10^4 copies/ml or 2000 IU/ml) or hepatitis C (positive hepatitis C antibody, and HCV-RNA above the lower limit of detection of the assay method). 9.Urinalysis indicates urinary protein >=++, and confirmed 24-hour urinary protein >1.0g. 10.Pregnant or lactating women. 11.Patients diagnosed with other malignant tumors within 5 years (except for cured basal cell carcinoma of the skin and carcinoma in situ of the cervix). 12.Patients with a history of psychoactive drug abuse that cannot be abstained from, or patients with mental disorders. 13.Patients who have participated in other drug clinical trials within four weeks. 14.Patients with concomitant diseases that, in the judgment of the investigator, pose a serious risk to patient safety or affect the completion of the study. 15.Patients considered unsuitable for inclusion by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| R0 resection rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Surgical conversion rate;Pathologic complete response rate;Major pathologic response rate;Lymph node downstaging rate;Disease-free survival;Overall survival;Safety outcomes (including adverse events and perioperative complications); | — |
Countries
China
Contacts
Public ContactLi Xiangnan and Zhao Jia
The First Affiliated Hospital of Zhengzhou University
Outcome results
None listed