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This is an investigator-initiated, single-arm, exploratory clinical study.The study population consisted of esophageal squamous cell carcinoma patients nonresponding to initial neoadjuvant chemoradiotherapy. The purpose of this study was to evaluate the efficacy and safety of immunotherapy combined with chemotherapy in the adjuvant treatment of esophageal squamous cell carcinoma after surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| experimental arm | Experimental | PF regimen (cis-platinum of 75mg/m2/d, d1; 5-fluorouracil of 600mg/m2d1-4) combined with PD-1 inhibitors(pembrolizumab,200mg d1) every 3 weeks for 4 cycles followed by PD-1 inhibitors(pembrolizumab,200mg d1)every 3 weeks up to 2 years in a standard manner. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF regimen (cis-platinum ; 5-fluorouracil ) combined with PD-1 inhibitors(pembrolizumab) | Drug | immunotherapy:PD-1 inhibitor chemotherapy:5-Fu and DDP |
|
| Measure | Description | Time Frame |
|---|---|---|
| Disease-free Survival (DFS) | Disease-free survival is defined as the time between date of surgery and first date of recurrence or death, whichever occurs first.Recurrence is defined as the appearance of one or more new lesions, which can be local, regional, or distant in location from the primary resected site ( assessed by imaging or pathology). All deaths without prior recurrence are considered as DFS events. | up to approximately 46 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | Overall survival is defined as the time from date of surgery to date of death from any cause. For subjects that are alive, their survival time was censored at the date of last contact date (or "last known alive date"). | up to approximately 46 months |
| Overall Survival Rate |
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Inclusion Criteria:
Exclusion Criteria:
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Overall survival rate is defined as the percentage of participants who are alive at 1, 2 and 3 years following surgery |
| From date of surgery to 1, 2 and 3 years later |
| ID | Term |
|---|---|
| C095424 | CF regimen |
| D002945 | Cisplatin |
| D005472 | Fluorouracil |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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