A Phase 4 interventional study of Tislelizumab + cisplatin + paclitaxel and Tislelizumab + radiotherapy in Esophageal Squamous Cell Carcinoma, sponsored by First Affiliated Hospital Xi'an Jiaotong University. Status unknown at 1 site in China. Open to participants aged 18 Years to 79 Years. Per ClinicalTrials.gov, last updated 2023-06-29.
Sponsored by First Affiliated Hospital Xi'an Jiaotong University · Phase 4, Interventional, and Treatment
Esophageal squamous cell carcinoma (ESCC), one of the most common subtypes of esophageal cancer, has a poor prognosis and low 5-year overall survival. At present, the treatment of ESCC includes chemotherapy, immunity, radiotherapy, surgery and other methods, and in recent years, the treatment regimen of immune combined chemotherapy has begun to show results in the treatment of esophageal cancer. Tislelizumab has demonstrated good efficacy in advanced esophageal cancer and in the second- and third-line treatment. At present, neoadjuvant immunization is carried out less, and neoadjuvant immunization plus chemoradiotherapy has been achieved With a pCR rate of 55.6 and AEs of grade III and above 65%, and studies have shown that radiotherapy has immunosensitizing and coordinating effects, whether immunotherapy combined with radiotherapy has a better efficacy is worth further investigation. This review intends to conduct a randomized, open-label, uncontrolled study of tislelizumab in combination with chemotherapy or radiation therapy for neoadjuvant therapy for resectable locally advanced thoracic esophageal squamous cell carcinoma with a view to providing a new option for resectable locally advanced ESCC.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's planned enrollment of 32 is below the median of 45 across 5,170 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →First Affiliated Hospital Xi'an Jiaotong University is the lead sponsor of 306 studies on the registry; 86 are open to participants now.
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(8) The main organs function normally, that is, meet the following standards:
Exclusion Criteria:
Drug: Tislelizumab + cisplatin + paclitaxel
Drug: Tislelizumab + radiotherapy
Tislelizumab 200mgD1 + cisplatin 75mg/m\^2D1 + paclitaxel 150mg/m\^2D1 Q3W 3 cycles
Tislelizumab 200mgQ3W 3 cycles + radiotherapy (23 times in total, 1.8 Gy per dose, 5 times a week)
Pathological complete response rate (pCR)
postoperative pathological examination shows no carcinological tissue residue
Time frame: From date of randomization until the date of first documented progression or date of death from any cause whichever came first, up to 100 weeks
Primary pathologic response rate (MPR)
postoperative pathological examination shows a residual \< of 10% of cancerous tissue
Time frame: From date of randomization until the date of first documented progression or date of death from any cause whichever came first, up to 100 weeks
Objective response rate (ORR) of primary lesions (RECIST v1.1)
the proportion of patients whose tumors shrink to a certain amount and remain for a certain period of time under imaging measurements, including complete response (CR, Complete Response) and partial response (PR, partial response) cases CR is defined as the complete disappearance of all target lesions except nodular disease. All target nodules must be reduced to normal size (minor axis\< 10 mm). All target lesions must be evaluated. PR is defined as the sum of the diameters of all measurable target lesions less than 30% ≥ baseline. The target nodule is summed and the short diameter is used, while all other target lesions are combined and the longest diameter is used. All target lesions must be evaluated.
Time frame: From date of randomization until the date of first documented progression or date of death from any cause whichever came first, up to 100 weeks
Disease-free survival (DFS)
the time between postoperative surgery and recurrence of disease or death (for any cause)
Time frame: From date of randomization until the date of first documented progression or date of death from any cause whichever came first, up to 100 weeks
Over all survival (OS)
the time from postoperative surgery to death (for any reason)
Time frame: From date of randomization until the date of first documented progression or date of death from any cause whichever came first, up to 100 weeks
Safety in the neoadjuvant phase and postoperative phase
according to the Common Acute and Subacute Toxicity Grading Standard (CTCAE 5.0), the adverse reactions after each immune combined radiotherapy or immune combined chemotherapy in the neoadjuvant therapy stage and the postoperative adverse reactions were evaluated
Time frame: From date of randomization until the date of first documented progression or date of death from any cause whichever came first, up to 100 weeks
Quality of life measurement and evaluation 1
according to the QLQ-C30 scale of the Quality of Life Survey, the quality of life after neoadjuvant therapy was assessed
Time frame: From date of randomization until the date of first documented progression or date of death from any cause whichever came first, up to 100 weeks
Quality of life measurement and evaluation 2
according to the QLQ-OES18 special scale for esophageal cancer, the quality of life after neoadjuvant therapy was assessed
Time frame: From date of randomization until the date of first documented progression or date of death from any cause whichever came first, up to 100 weeks
Plan to share: No
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This study is status unknown, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
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First Affiliated Hospital Xi'an Jiaotong University