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Neoadjuvant Immunotherapy Plus CRT Versus Neoadjuvant CRT for Locally Advanced Resectable ESCC

RecruitingPhase 2, Phase 3Ages 18 Years - 75 YearsAllShanghai Zhongshan Hospital
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In plain words

What the trial is, and whether it could suit you

The purpose of this study was to evaluate the safety, feasibility and outcome of anti-PD-1 antibody (Tislelizumab, BeiGene) combined with neoadjuvant chemoradiotherapy versus neoadjuvant chemoradiotherapy followed by minimally invasive esophagectomy for locally advanced resectable esophageal squamous cell carcinoma (cII-III Stage) patient.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: 1. Histologically-confirmed esophageal squamous cell carcinoma and whose tissue samples were taken before treatment; 2. Tumors of the esophagus are located in the thoracic cavity; 3. Pre-treatment stage as clinical II-III (AJCC/UICC 8th Edition) 4. Age is between 18 years and 75 years; 5. Eastern Cooperative Oncology Group (ECOG) performance status 0-1, and expected survival time ≥12 months; 6. Adequate cardiac function. All patients should perform ECG, and those with a cardiac history or ECG abnormality should perform echocardiography with the left ventricular ejection fraction \> 50 %; 7. Adequate respiratory function with FEV1≥1.2L, FEV1%≥50% and DLCO≥50% shown in pulmonary function tests ; 8. Adequate bone marrow function (White Blood Cells \>4x10\^9 /L; Neutrophil \>2.0×10\^9 /L; Hemoglobin \> 90 g/L; platelets\>100x10\^9 /L); 9. Adequate liver function (Total bilirubin \<1.5x Upper Level of Normal (ULN); Aspartate transaminase(AST) and Alanine transaminase (ALT) \<1.5x ULN); 10. Adequate renal function (Glomerular filtration rate (CCr) \>60 ml/min; serum creatinine (SCr) ≤120 µmol/L); 11. The patient has provided written informed consent and is able to understand and comply with the study; Exclusion Criteria: Exclusion Criteria associated with Cancer: 1. Patients with histological non-squamous cell carcinoma; 2. Patients with advanced non-operable or metastatic esophageal cancer; 3. Pre-treatment stage as cM+, cN3 or cT4b(non-curatively-resectable verified by the local surgical investigator, AJCC/UICC 8th Edition) or cTis-1a, cT1bN0; 4. Patients with another previous or current malignant disease which is likely to interfere with treatment or the assessment of response in the judgement of the local surgical investigator; 5. Patients who have received or are receiving other chemotherapy, radiotherapy or targeted therapy; Other Exclusion Criteria: 6. Patients with autoimmune diseases history; 7. Recently or currently taking Glucocorticoids or Immunosuppressants; 8. Patients who underwent immunotherapy in the past; 9. Allergy to any antibody drugs or allergy to Paclitaxel and Carboplatin. 10. Past or currently suffering from chronic or recurrent autoimmune diseases; 11. Patients with active infection of immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV); HIV seropositivity; HBV DNA or HCV RNA positive; 12. Patients with organ transplantation (including autologous bone marrow transplantation and peripheral stem cell transplantation); 13. Patients with severe systematic intercurrent disease, such as active infection or poorly controlled diabetes; coagulation disorders; hemorrhagic tendency or under treatment of thrombolysis or anticoagulant therapy; 14. Any patient with a significant medical condition which is thought unlikely to tolerate the therapies. Such as cardiac disease (e.g. symptomatic coronary artery disease or myocardial infarction within last 12 months), clinically-significant lung disease, clinically-significant bone marrow, liver, renal function disorder; 15. Pregnant or lactating women and fertile women who will not be using contraception during the trial; 16. Participation in another intervention clinical trial with interference to the chemotherapeutic or chemoradiotherapeutic intervention during this study or during the last 30 days prior to informed consent; 17. Expected lack of compliance with the protocol.
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What it tests

  • Neoadjuvant Chemoradiotherapy
  • Tislelizumab
  • Ivor-Lewis or Mckeown Esophagectomy(Mckeown Esophagectomy recommended)
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Where

1 site
Shanghai Zhongshan Hospital
Shanghai, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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