Serplulimab Combined With Chemotherapy in Patients With Resectable Esophageal Squamous Cell Carcinoma

Study Overview
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Brief Summary
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China with high incidence of esophageal cancer, the number of new cases and deaths account for about 50% of the world every year. In the past few decades, surgery, radiotherapy, chemotherapy and other treatments were continuously improved, however, the mortality of esophageal squamous cell carcinoma patients was not significantly decreased. For patients with locally advanced esophageal cancer, direct surgery is not effective. It is difficult to achieve radical resection by surgery merely, and even if many patients receive surgery, they may eventually have tumor recurrence and poor survival rate. Therefore, it is necessary to explore effective perioperative neoadjuvant treatment to reduce the risk of postoperative recurrence and improve the postoperative survival rate of patients. According to the reports, the expression of PD-L1 in esophageal cancer was about 41.4%. Therefore, PD-1/ PD-L1 immunocheckpoint inhibitor may become a new method for the treatment of esophageal cancer. Preliminary clinical results showed that immunotherapy combined with chemoradiotherapy provided a synergies antitumor effect. Multiple clinical results showed that serplulimab provided higher overall response rate for advanced esophageal cancer. However, in patients with locally advanced esophageal cancer, the efficacy of serplulimab combined with chemotherapy for sequential radical surgery is still unclear. The purpose of this study is to observe and evaluate the efficacy and safety of silulimab combined with chemotherapy in the neoadjuvant therapy of resectable esophageal squamous cell carcinoma.

Official Title
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A Prospective, Single-arm, Single-center, Exploratory Study of the Safety and Efficacy of Serplulimab Combined With Chemotherapy in Patients With Resectable Esophageal Squamous Cell Carcinoma

Conditions
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Esophageal Squamous Cell Carcinoma, Neoadjuvant Therapy

Intervention / Treatment
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* Combination Product: Serplulimab, Albumin paclitaxel, carboplatin AUC=5, neoadjuvant therapy
* Procedure: Esophagectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: signed informed consent; patients age 18 to 75 years old primary resectable, histologically confirmed esophageal squamous cell cancer; Esophageal squamous cell carcinoma the clinical stage was IIA-IVA (according to AJCC TNM stage, 8th edition). ECOG PS 0-1. No distant metastasis, the diseases could be resectable assessed by thoracic oncologist; Exclusion Criteria: with significant cardiovascular disease; current treatment with anti-viral therapy or HBV; Female patients who are pregnant or lactating; history of malignancy within 5 years prior to screening; active or history of autoimmune disease or immune deficiency; signs of distant metastases.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Combination Product: Serplulimab, Albumin paclitaxel, carboplatin AUC=5, neoadjuvant therapy|Serplulimab 4.5mg/kg, IV, Day 1; Albumin paclitaxel 260mg/m2, Day 1; carboplatin AUC=5, Day 1; Preoperative neoadjuvant therapy for 2-4 cycles, one cycle every 21 days.|
|Procedure: Esophagectomy|Laparoscopy combined with thoracoscope radical resection of esophageal carcinoma|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Pathological Response (MPR) | In the pathological examination of resected specimens, the proportion of residual tumor cells was less than 10%. | 1 month after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pathological Complete Response (PCR) | No residual invasive tumor cells were found in the pathological examination of resected specimens. | 1 month after surgery | 
| Objective Response Rate (ORR) | The proportion of subjects with imaging PR or CR assessed according to RECIST 1.1 criteria | before surgery | 
| 2-year and 5-year overall survival | The proportion of all study cases in which no death from any cause occurred within 2 years and 5 years after surgery | 2-year and 5-year after surgery | 
| Incidence of Treatment-related Adverse Events | Incidence of Treatment-related Adverse Events as Assessed by CTCAE v5.0 | 1 month after surgery | 
| R0 resection rate | The pathological results will showed that the incision margin was negative and no residual cancer cells were found under the microscope | 1 month after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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serplulimab, Esophageal Squamous Cell Carcinoma, Neoadjuvant Treatment