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

Launched by SHANGHAI ZHONGSHAN HOSPITAL · Jul 13, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with locally advanced esophageal squamous cell carcinoma, which is a type of cancer in the esophagus. The trial is comparing two treatment methods: one that combines a special immune therapy drug called Tislelizumab with chemoradiotherapy (which uses chemotherapy and radiation together) and another that uses just chemoradiotherapy followed by surgery to remove the tumor. The goal is to see if the combination treatment is safe and effective.

To participate in this trial, patients must be between 18 and 75 years old and have a confirmed diagnosis of esophageal squamous cell carcinoma that can be treated with surgery. They should also have good overall health, meaning their heart, lungs, and other vital functions are working well. Participants can expect to undergo the assigned treatment and will be monitored closely for their health and any side effects. It's important to note that certain patients, such as those with other active cancers or serious health conditions, may not be eligible to join. This trial is currently recruiting participants, so those interested should discuss it with their doctor.

Gender

ALL

Eligibility criteria

• 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.