Esophageal carcinoma
Conditions
Interventions
Cohort A(locally advanced resectable esophageal cancer):The patient should undergo a tumor assessment within 6 weeks after 3 cycles of chemotherapy combined with immunotherapy.
Cohort B(oligometastatic esophageal cancer):The patient should undergo a tumor assessment within 6 weeks after 3 cycles of chemotherapy combined with immunotherapy.
Cohort C(metastatic esophageal cancer):The patient needs to undergo 6 cycles of chemotherapy combined with immunotherapy, and then enter the maintenance stage of immunotherapy.
Sponsors
The First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: Locally advanced esophageal cancer or esophageal cancer with oligometastasis or widespread metastasis meeting the following criteria will be recruited. 1. Age 1. 18-80 years old, male and female 2. Pathology confirmed locally advanced resectable (T2N0M0, T1b-2N+M0, T3-4aNanyM0) or metastatic (TanyNanyM1) squamous cell carcinoma 3. Cohorts A and B, ECOG: 0 to 1; Cohort C, ECOG: 0 ~ 2 4. Expected survival >=12 weeks 5. If the major organs function normally, the following criteria are met: (1) Blood routine examination: a.HB>=90g/L; b.ANC>=1.5×10^9/L; C. PLT >=80×10^9/L; (2) Biochemical examination: A.LB >=30g/L; B.lt and AST=60ml/min 6. Doppler ultrasound evaluation: left ventricular ejection fraction (LVEF) >= the lower limit of normal value (50%) 7. Women of reproductive age should agree to use contraceptives (such as Iuds, contraceptives or condoms) during the study period and for 6 months after the study ends; Have a negative serum or urine pregnancy test within 7 days prior to study enrollment and must be a non-lactating patient; Men should consent to patients who must use contraception during the study period and for 6 months after the end of the study period 8. Subjects voluntarily joined the study, signed informed consent, had good compliance, and cooperated with follow-up. Remarks: 1 Clinical staging was based on AJCC 9th. 2 The clinical stage of cohort A and cohort B should be evaluated by ultrasound gastroscopy during the screening period. 3. On imaging (CT or color ultrasound), lymph node short diameter >=1cm is considered to be lymph node metastasis. On PET-CT, metastasis is determined according to the SUV cut-off value of each center. 4 Each patient should have a multidisciplinary discussion with the MDT team, which includes specialists in thoracic surgery, radiotherapy and medical oncology.
Exclusion criteria
Exclusion criteria: 1. People who are allergic to sindillizumab, paclitaxel or platinum or have metabolic disorders 2. Have known contraindications to sindillizumab, paclitaxel, or platinum 3. The patient has any active autoimmune disease or a history of autoimmune disease (e.g., but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism; The patient had vitiligo; Those with complete remission of asthma in childhood can be included without any intervention in adulthood; Patients with asthma requiring medical intervention with bronchodilators are not included) 4. Patients who are taking immunosuppressants or systemic hormone therapy for immunosuppressive purposes (dose >10mg/ day prednisone or other therapeutic hormones) and continue to use within 2 weeks before enrollment 5. Patients with any severe and/or uncontrolled heart disease, including: patients with unsatisfactory blood pressure control (systolic blood pressure >=150mmHg or diastolic blood pressure >=100 mmHg); Heart failure due to coronary heart disease, cardiomyopathy, or other causes of heart function grade III-IV (NYHA scale). 6. Other serious medical diseases: active or uncontrolled serious infections; Liver diseases such as decompensated liver disease, active hepatitis B (HBV-DNA=104 copy numbers /ml or 2000IU/ml), or hepatitis C (hepatitis C antibody positive and HCV-RNA above the lower detection limit of analytical methods); Urine routine indicated urine protein =++, and confirmed 24-hour urine protein quantity > 1.0g 7. Pregnant or lactating women 8. Patients who have had other malignancies within 5 years (except basal cell carcinoma of the skin and carcinoma in situ of the cervix that has been cured) 9. Patients who have a history of psychotropic drug abuse and cannot quit or have mental disorders 10. Patients who have participated in clinical trials of other drugs within four weeks 11. Patients with concomitant diseases that, in the judgment of the investigator, seriously endanger the patient's safety or interfere with the patient's completion of the study 12. Those deemed unsuitable for inclusion by the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Median survival time; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease-Free Survival ; Treatment Response;R0 Resection Rate;Medication Safety;Pathological Response Rate;Perioperative Complications and Mortality; Patient-Reported Outcomes; | — |
Countries
China
Contacts
Public ContactLi Xiangnan
The First Affiliated Hospital of Zhengzhou University
Outcome results
None listed