Neoadjuvant Immunotherapy Combined With Chemoradiotherapy Versus Neoadjuvant Chemoradiotherapy for Locally Advanced Resectable Esophageal Squamous Cell Carcinoma (cII-III Stage): A Multi-center Prospective Randomized Clinical Trial

Who is this study for? Patients with locally advanced resectable esophageal squamous cell carcinoma
What treatments are being studied? Neoadjuvant Chemoradiotherapy+Tislelizumab+Ivor-Lewis or Mckeown Esophagectomy
Status: Recruiting
Location: See location...
Intervention Type: Drug, Procedure
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Histologically-confirmed esophageal squamous cell carcinoma and whose tissue samples were taken before treatment;

• Tumors of the esophagus are located in the thoracic cavity;

• Pre-treatment stage as clinical II-III (AJCC/UICC 8th Edition)

• Age is between 18 years and 75 years;

• Eastern Cooperative Oncology Group (ECOG) performance status 0-1, and expected survival time ≥12 months;

• 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 %;

• Adequate respiratory function with FEV1≥1.2L, FEV1%≥50% and DLCO≥50% shown in pulmonary function tests ;

• Adequate bone marrow function (White Blood Cells \>4x10\^9 /L; Neutrophil \>2.0×10\^9 /L; Hemoglobin \> 90 g/L; platelets\>100x10\^9 /L);

• Adequate liver function (Total bilirubin \<1.5x Upper Level of Normal (ULN); Aspartate transaminase(AST) and Alanine transaminase (ALT) \<1.5x ULN);

⁃ Adequate renal function (Glomerular filtration rate (CCr) \>60 ml/min; serum creatinine (SCr) ≤120 µmol/L);

⁃ The patient has provided written informed consent and is able to understand and comply with the study;

Locations
Other Locations
China
Shanghai Zhongshan Hospital
RECRUITING
Shanghai
Time Frame
Start Date: 2022-03-02
Estimated Completion Date: 2027-07
Participants
Target number of participants: 176
Treatments
Experimental: Neoadjuvant chemoradiotherapy combined with anti-PD-1 antibody
Neoadjuvant chemoradiotherapy (NCRT) combined with tislelizumab is performed followed by Ivor-Lewis or Mckeown esophagectomy in enrolled patients.
Active_comparator: Neoadjuvant chemoradiotherapy
Neoadjuvant chemoradiotherapy (NCRT) is performed followed by Ivor-Lewis or Mckeown esophagectomy in enrolled patients.
Related Therapeutic Areas
Sponsors
Collaborators: Shanghai Fifth People's Hospital, Shanghai Chest Hospital, First Affiliated Hospital of Wenzhou Medical University, Shanghai Minhang Central Hospital, Ningbo Medical Center Lihuili Hospital, Peking University Cancer Hospital & Institute, Zhongshan Hospital (Xiamen), Fudan University, Sichuan Cancer Hospital and Research Institute, Xuhui Central Hospital, Shanghai, The First People's Hospital of Changzhou, Zhejiang Cancer Hospital, Sun Yat-sen University, Tongji Hospital, Tianjin Medical University Cancer Institute and Hospital, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Leads: Shanghai Zhongshan Hospital

This content was sourced from clinicaltrials.gov

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