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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chemotherapy | Active Comparator |
| |
| Radiotherapy | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tislelizumab + cisplatin + paclitaxel | Drug | Tislelizumab 200mgD1 + cisplatin 75mg/m^2D1 + paclitaxel 150mg/m^2D1 Q3W 3 cycles |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pathological complete response rate (pCR) | postoperative pathological examination shows no carcinological tissue residue | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Primary pathologic response rate (MPR) | postoperative pathological examination shows a residual < of 10% of cancerous tissue | 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) |
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Inclusion Criteria:
(1) The subjects voluntarily joined the study and signed the informed consent form, with good compliance and follow-up;
(2) 18 years old≤ age≤ 79 years old, male or female;
(3) ECOG score 0~1 points;
(4) Patients with pathological (histological or cytology) confirmed esophageal squaf cell carcinoma; According to the eighth edition of the clinical tumor TNM stage, subjects were resectable cT2-4aNanyM0;
(5) Have measurable lesions (according to RECIST 1.1 criteria, tumor lesion CT scan length diameter≥ 10mm lymph node lesion CT scan short diameter ≥15mm);
(6) Those who were first diagnosed with esophageal squamous cell carcinoma before enrollment and did not undergo radiotherapy, chemotherapy, immunity, surgery and targeted therapy;
(7) Able to eat a liquid diet or above, no signs before esophageal perforation or esophageal ulcers, and able to tolerate surgery;
(8) The main organs function normally, that is, meet the following standards:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Junke Fu | First Affiliated Hospital Xi'an Jiaotong University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Xi'an Jiaotong University | Xi'an | Shaanxi | 710061 | China |
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Cohort study
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| Tislelizumab + radiotherapy | Drug | Tislelizumab 200mgQ3W 3 cycles + radiotherapy (23 times in total, 1.8 Gy per dose, 5 times a week) |
|
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. |
| 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) | 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) | 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 | 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 | 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 | 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 |
| ID | Term |
|---|---|
| D000077277 | Esophageal Squamous Cell Carcinoma |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D018307 | Neoplasms, Squamous Cell |
| D004938 | Esophageal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| C000707970 | tislelizumab |
| D002945 | Cisplatin |
| D017239 | Paclitaxel |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D013812 | Therapeutics |
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