A Phase 2/3 interventional study of Neoadjuvant Chemoradiotherapy and Tislelizumab in Esophageal Squamous Cell Carcinoma Stage II and Esophageal Squamous Cell Carcinoma Stage III, sponsored by Shanghai Zhongshan Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-06-30.
Sponsored by Shanghai Zhongshan Hospital · Phase 2/3, Interventional, and Treatment
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.
It is a prospective randomized phase II\&III clinical trial sponsored by Shanghai Zhongshan Hospital with other twelve hospitals in China participating in. 476 patients with locally advanced resectable esophageal squamous cell carcinoma (cII-III Stage) are recruited and randomly assigned into the neoadjuvant chemoradiotherapy combined with immunotherapy group (nCRT plus anti-PD-1 Group) and the neoadjuvant chemoradiotherapy group (nCRT Group) according to the proportion of 1:1. The safety, efficacy of protocols and prognosis of patients are compared between the two regimens.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's planned enrollment of 176 is above the median of 45 across 5,170 interventional studies indexed under Carcinoma.
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Inclusion Criteria:
Exclusion Criteria:
Exclusion Criteria associated with Cancer:
Patients who have received or are receiving other chemotherapy, radiotherapy or targeted therapy;
Other Exclusion Criteria:
Neoadjuvant chemoradiotherapy (NCRT) combined with tislelizumab is performed followed by Ivor-Lewis or Mckeown esophagectomy in enrolled patients.
Procedure: Neoadjuvant Chemoradiotherapy · Drug: Tislelizumab · Procedure: Ivor-Lewis or Mckeown Esophagectomy(Mckeown Esophagectomy recommended)
Neoadjuvant chemoradiotherapy (NCRT) is performed followed by Ivor-Lewis or Mckeown esophagectomy in enrolled patients.
Procedure: Neoadjuvant Chemoradiotherapy · Procedure: Ivor-Lewis or Mckeown Esophagectomy(Mckeown Esophagectomy recommended)
Chemotherapy: carboplatin (AUC 2 mg/mL per min) and paclitaxel (50 mg/m2 of body-surface area) were administered intravenously for five cycles, starting on days 1, 8, 15, 22, and 29. For each cycle, Carboplatin and paclitaxel were administered 30 minutes apart. Radiotherapy: A total radiation dose of 41.4 Gy was given in 23 fractions of 1.8 Gy, 5 days per week (Radiotherapy was performed on the 2nd, 3rd, 4th, 5th, and 6th day in each cycle, and only 3 times in the 5th cycle)
Tislelizumab (200mg/time) was administered intravenously on the 1st and 22nd day. The intravenous injection lasts about 30 minutes (micropump is recommended, intravenous bolus is prohibited, duration should be not less than 20 minutes and not more than 60 minutes);
Also known as: anti-PD-1 antibody
After neoadjuvant therapy, patients in groups receive Ivor-Lewis or Mckeown Esophagectomy (Mckeown Esophagectomy recommended)
Pathological response rate(pCR)
The resected specimen following neo-adjuvant treatment are assessed by using standardized work up of the resection specimen in the pathology department and standardized histological criteria for tumor regression grading. The degree of histomorphologic regression is clarified into four categories as follows: grade 1, no evidence of vital residual tumor cells (pathological complete response); grade 2, less than 10% vital residual tumor cells; grade 3, 10 to 50%; and grade 4, more than 50%.
Time frame: Up to the date of pathological reports obtained since the date of randomization, up to 12 months
Overall survival(OS)
Time frame: Up to the date of death of any causes since the date of randomization, up to 36 months
Treatment related complications
Number and severity of adverse events that are related to treatment of each patients (including adverse events associated with neoadjuvant chemoradiotherapy, immunotherapy(irAE) and surgery), and hospital re-admission. Treatment-related adverse events as assessed by CTCAE v5.0
Time frame: Up to 1 month after surgery since the data of randomization, up to 13 months
Progression-free survival(PFS)
Disease recurrence is defined as locoregional (esophageal bed or anastomotic or regional lymph nodes) or metastatic (supraclavicular lymph nodes or distant organs)
Time frame: Up to the date of disease recurrence since the date of randomization, up to 36 months
R0 resection rate
No vital tumor is presented at the proximal, distal, or circumferential resection margin, it is considered to be R0 resection. If a vital tumor is shown at 1 mm or less from the proximal, distal, or circumferential resection margin, it is considered to be microscopically positive (R1).
Time frame: Up to the date of pathological reports obtained since the date of randomization, up to 12 months
Number and Location of positive lymph nodes
According to pathological reports, record the number and location of positive lymph nodes
Time frame: Up to the date of pathological reports obtained since the date of randomization, up to 12 months
Overall Quality of life
Overall Quality of life is respectively evaluated at randomization and 1 month, 3 month, 6 month and yearly after surgery among patients by using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C-30 Scale (EORTC QLQ-C30)
Time frame: Up to the end of follow-up since the data of surgery, up to 36 months
Quality of life in eating and swallowing function
Quality of life in eating and swallowing function is respectively evaluated at randomization and 1 month, 3 month, 6 month and yearly after surgery among patients by using the EORTC QLQ-OES18 Scale
Time frame: Up to the end of follow-up since the data of surgery, up to 36 months
Recurrence-free survival (RFS)
RFS is defined in resected patients who achieved an R0 or R1 resection as the time interval from surgery to the date of first recurrence (local, regional or distant) or death, whichever comes first.
Time frame: Up to the date of disease recurrence since the date of surgery, up to 36 months
Correlation between genetic profile and tumor response
Genetic profile (assessed by whole exome sequencing, T-cell receptor sequencing, RNA sequencing) .illumina HiSeq and Nanostring platforms will be used to evaluate the patient's genetic profile. The tumor response will be evaluated by an experienced thoracic tumor pathologist in our center through Tumor regression grading (TRG) systems.
Time frame: Up to the end of follow-up since the data of surgery, up to 36 months
Plan to share: No — According to the regulations on the management of human genetic resources of the People's Republic of China, we will not be able to share Individual Participant Data
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Shanghai Zhongshan Hospital