A Phase 2 interventional study of Sintilimab + chemotherapy in Esophageal Squamous Cell Carcinoma, sponsored by The First Affiliated Hospital of Soochow University. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-12-30.
Sponsored by The First Affiliated Hospital of Soochow University · Phase 2, Interventional, and Treatment
This study aims to evaluate the efficacy of sintilimab combined with concurrent chemotherapy as a neoadjuvant treatment for patients with operable esophageal squamous cell carcinoma. It will also evaluate the changes in the immune microenvironment of tumor specimens before and after the medication, and predict the operable period (stage I\~III) Patients with thoracic esophageal squamous cell carcinoma were treated with neoadjuvant chemotherapy combined with PD-1 monoclonal antibody, and the effect of neoadjuvant chemotherapy combined with PD-1 monoclonal antibody was evaluated by detecting the changes of microbial diversity and metabolites in stool samples before and after treatment.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's planned enrollment of 30 is below the median of 45 across 5,170 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →The First Affiliated Hospital of Soochow University is the lead sponsor of 252 studies on the registry; 148 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Pre-operative Sintilimab + chemotherapy
Drug: Sintilimab + chemotherapy
Biological : Sintilimab 100mg: 10ml Method of administration: 200mg IV D1 Q3W. Drug: Cisplatin Injection Specification: 75mg/m2, IV D1 Q3W. Drug: Albumin Paclitaxel Injection specifications: 260mg/m2, IV D1 Q3W.
Pathologic complete remission (PCR)
Primary tumor or lymph node surgery specimen pathological examination without residual tumor cell
Time frame: 4 weeks after surgery
Objective Response Rate (ORR)
Objective Response Rate Determine the tumor shrinkage rate, tumor boundary and the adhesion of tumor
Time frame: 4 weeks after surgery
Radiographic response
To assess radiographic response to neoadjuvant pembrolizumab with concurrent chemoradiotherapy using RECIST 1.1.
Time frame: From date of treatment allocation and during treatment period up to 3 months
This study is status unknown, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.
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The First Affiliated Hospital of Soochow University