Preoperative Immune checkpoint inhibitors combined with chemotherapy have revolutionized the treatment landscape of locally advanced esophageal squamous cell carcinoma. However, there are still a significant proportion of patients who could not benefit from such treatment modality. Currently, no effective biomarkers were identified to stratify responders and non-responders. Early dynamic and persistent relief of dysphagia may act as a predictive biomarker to reflect the on-treatment anti-tumor activity. In this prospective study, we aimed to explore the feasibility of using patient-reported outcomes (PROs) to predict the pathological complete response of esophageal squamous cell carcinoma patients treated with neoadjuvant immunochemotherapy with or without short-term radiation as well as to assess the efficacy and safety of short-term radiotherapy in PROs-insensitive patients after one cycle of neoadjuvant immunochemotherapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
260mg/m2, ivdrip, d1
60mg/m2, ivdrip, d1
AUC=4-6, ivdrip, d1
200mg, ivdrip, d1
15Gy/5F (d43-d50, d57-d64), 5 times a week
Minimally-invasive or open McKeown and Ivor-Lewis esophagectomy
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
RECRUITINGPathologic complete response rate
The rate of pathologic complete response rate after the combined treatment of chemotherapy and immunotherapy following surgery
Time frame: Three to five working days after surgery
Objective Response Rate (ORR)
iRECIST criteria defined complete response and partial response
Time frame: Up to 24 weeks
Safety as measured by number of participants with Grade 3 and 4 adverse events
Number of Grade 3 and 4 adverse events as defined by CTCAE v5.0
Time frame: Up to 12 weeks
R0 resection rate R0 resection rate R0 resection rate R0 resection rate R0 resection rate R0 resction rate
The R0 resection rate of esophagectomy
Time frame: Three to five working days after surgery
Major pathological response
less than 10% residual viable tumor follow neoadjuvant therapy
Time frame: Three to five working days after surgery
Overall survival
Overall survival rate
Time frame: From the date of diagnosis to the date of death, assessed up to 100 months
Event-free survival
EFS
Time frame: From the date of treatment initiation to the date of first progression (local recurrence of tumor or distant metastasis) or death from any cause, assessed up to 100 months
Dysphagia relief score
DRS
Time frame: score calculated by EORTC OES-18 dysphagia scale criteria at each cycle up to 6 months
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