This is a multi-center, single-arm, phase II clinical study designed to observe and evaluate the effectiveness and safety of adebrelimab combined with albumin paclitaxel and nedaplatin as neoadjuvant therapy for locally advanced resectable esophageal squamous cell carcinoma.
This study plans to include 65 patients who received 3 cycles of neoadjuvant therapy (Adebrelimab + albumin paclitaxel + nedaplatin) , and underwent surgery after the treatment was completed. The purpose of this study is to explore and evaluate the effectiveness and safety of adebrelimab combined with albumin paclitaxel and nedaplatin as neoadjuvant therapy for locally advanced resectable esophageal squamous cell carcinoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
65
pathological complete remission rate
After neoadjuvant therapy and surgery, there were no residual surviving tumor cells in the tumor bed in the postoperative specimens (% RVT=0)
Time frame: up to 24 months
R0 resection rate
The tumor lesion was completely removed, and no residual cancer cells were found on the cutting edge under the microscope
Time frame: up to 24 months
Main pathological remission
After neoadjuvant therapy and surgery, the proportion of tumor cells remaining alive in the tumor bed in the postoperative specimen is less than or equal to 10% (% RVT ≤ 10)
Time frame: up to 24 months
objective response rate
The proportion of patients whose tumors have shrunk to a certain amount and remained in remission for a certain period of time, including complete response (CR) and partial response (PR).
Time frame: up to 24 months
Disease-free survival
It was calculated from the time of first administration of study drug until disease progression or death.
Time frame: up to 24 months
overall survival
The time is calculated from the first administration of the study drug until death due to any cause (patients who were lost to follow-up are the last follow-up time; patients who are still alive at the end of the study are the end of follow-up date).
Time frame: up to 24 months
Number of participants with treatment related adverse events asassessed by CTCAE v5.0
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Proportion of patients with treatment-related adverse events recorded using CTCAE 5.0 criteria
Time frame: up to 24 months
Changes in the patient's mood
Use PHQ-9 and GAD-7 to record the changes in patients' emotions during treatment
Time frame: up to 24 months
The patient's nutritional status
Use PNI, CNI and mCONUT scoring standards to record changes in the patient's nutritional status during treatment
Time frame: up to 24 months
The pain level of patients
NRS and VAS pain rating scales were used to assess changes in patients' pain levels during treatment.
Time frame: up to 24 months