The Phase II Trial of SHR-1210 Combined With Preoperative Chemotherapy or Apatinib for Locally Advanced ESCC

  • End date
    Oct 7, 2024
  • participants needed
  • sponsor
    The First Affiliated Hospital of Zhengzhou University
Updated on 9 March 2022


The purpose of this study is to observe and evaluate the efficacy and safety of SHR-1210 combined with preoperative chemotherapy or Apatinib for locally advanced esophageal squamous cell carcinoma


In China, the incidence of esophageal cancer has declined in recent years, but the mortality rate has been ranked fourth. Morbidity and mortality were ranked sixth and fourth in all malignancies, respectively. Therefore, esophageal cancer has always been a major malignant tumor that threatens the health of our residents. Investigator designed a single-arm, open-label, phase II trial of SHR-1210 combined with preoperative chemotherapy or Apatinib for locally advanced esophageal squamous cell carcinoma. The purpose of this study is to observe and evaluate the efficacy and safety of SHR-1210 combined with preoperative chemotherapy or Apatinib for locally advanced esophageal squamous cell carcinoma.

Condition Locally Advanced Esophageal Squamous Cell Carcinoma
Treatment SHR-1210+docetaxel+nedaplatin, SHR-1210+Apatinib
Clinical Study IdentifierNCT03917966
SponsorThe First Affiliated Hospital of Zhengzhou University
Last Modified on9 March 2022


Yes No Not Sure

Inclusion Criteria

Age 18-80 years old, both men and women
Histology confirmed as esophageal squamous cell carcinoma
Resectable stage Ⅱ/Ⅲ/Ⅳa(cT2-4aN0-3M0)
ECOG: 0~1
Expected survival period≥12 weeks
The main organs function normally, that is, the following criteria are met:(1)Blood routine examination:a.HB≥90g/L; b.ANC≥1.5×109 / L; c.PLT≥80×109 / L (2)Biochemical examination:a.ALB≥30g / L; b.ALT and AST≤2.5ULN; if there is liver metastasis, ALT and AST ≤ 5ULN; c.TBIL ≤1.5ULN;d.plasma Cr≤1.5ULN or creatinine clearance (CCr) ≥ 60ml / min
Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) ≥ normal low limit (50%)
Women of childbearing age should agree to use contraceptives (such as intrauterine devices, contraceptives or condoms) during the study period and within 6 months after the end of the study; negative serum or urine pregnancy test within 7 days prior to study enrollment And must be non-lactating patients; males should agree to patients who must use contraception during the study period and within 6 months after the end of the study period
Subjects voluntarily joined the study, signed informed consent, and were well-adhered to follow-up
Can swallow tablets normally

Exclusion Criteria

Those who are allergic to or sensitive to Docetaxel and nedaplatin
Patients with any severe and/or uncontrolled diseases:Patients with unsatisfactory blood pressure control (systolic blood pressure ≥150mmHg or diastolic blood pressure ≥100 mmHg); myocardial ischemia or myocardial infarction with grade I or above, arrhythmia (including QT interval ≥480ms) and grade I cardiac insufficiency
Liver diseases such as decompensated liver disease, active hepatitis B (HBV-DNA ≥ 104 copies/ml or 2000 IU/ml) or hepatitis C (positive hepatitis C antibody, and HCV-RNA is higher than the lower limit of detection of the analytical method)
Urine routine indicates that urine protein ≥ ++, and confirmed 24-hour urine protein quantitation > 1.0g
Does not meet the above inclusion criteria
The patient has any active autoimmune disease or a history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis,Hyperthyroidism; patients with vitiligo; Asthma has been completely relieved in childhood, and patients who do not need any intervention after adulthood can be included; asthma patients who require bronchodilators for medical intervention cannot be included)
The patient is using immunosuppressive agents or systemic hormonal therapy for immunosuppressive purposes (dose > 10 mg/day of prednisone or other therapeutic hormones) and continues to be used for 2 weeks prior to enrollment
Patients with esophageal squamous cell carcinoma whose primary focus is active bleeding
Active or uncontrolled serious infections
With active ulcer, unhealed wound or fracture
Suffer from hypertension and cannot be well controlled by antihypertensive drugs (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg)
Pregnant or lactating women
Abnormal coagulation function (INR > 2.0 or prothrombin time (PT) > 16S), bleeding tendency or undergoing thrombolytic or anticoagulant therapy (preventive use of low-dose aspirin and low molecular weight heparin is allowed)
Patients with other malignancies within 5 years (except for basal cell carcinoma and cervical carcinoma in situ) that have been cured
Patients with clinically significant bleeding symptoms or definite bleeding tendency within the first three months of randomization, such as gastrointestinal bleeding, hemorrhagic gastric ulcer or vasculitis, can be reexamined if the stool occult blood is positive in the baseline period. If it is still positive after reexamination, endoscopic examination is required (except those who have accepted endoscopic examination within three months before enrollment and excluded such cases)
Patients with a history of psychotropic substance abuse who are unable to quit or have a mental disorder
Arteriovenous thrombosis events occurred within the first 6 months of randomization, such as cerebrovascular accidents (including transient ischemic attack, intracerebral hemorrhage and cerebral infarction), deep venous thrombosis and pulmonary embolism
Patients who have participated in other drug clinical trials within four weeks
Known hereditary or acquired bleeding and thrombotic tendency (such as hemophilia, coagulation dysfunction, thrombocytopenia, etc.)
At the discretion of the investigator, there are patients with serious concomitant disease that compromises patient safety or affects the patient's completion of the study
Routine urine examination showed that urinary protein was ≥ + + and it was confirmed that the amount of urinary protein in 24 hours was > 1.0 g
The investigator believes that it is not suitable for inclusion
Patients with supraclavicular lymph node metastasis; Poor nutritional status, BMI < 18.5 kg / m2; If it is corrected before randomization after symptomatic nutritional support, it can continue to be considered after evaluation by the main investigator
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