Our previous study, a single-center, prospective, single-arm Phase II study (Keypoint001) has demonstrated the efficacy and safety of neoadjuvant chemotherapy combined with immunotherapy in locally advanced (cT3-4N+M0) esophageal squamous cell carcinoma. The results show that the pathological complete response rate (pCR) reaches 35%, and the major pathological response rate is over 70%, which is much higher than that of patients receiving chemotherapy alone. Meanwhile, no severe adverse drug reactions have been found in terms of safety, so this treatment regimen is safe and reliable. However, the cycle of neoadjuvant immunotherapy is still under exploration. Currently, the mainstream research centers adopt a regimen of 2 to 4 cycles. The exploration results of our center have found that most patients' conditions can be further alleviated after 4 cycles compared with after 2 cycles, but there are still a small number of patients with no obvious remission. Therefore, we consider observing whether patients with no obvious remission can achieve a better pathological response rate through further radiotherapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
carboplatin plus nab-paclitaxel
Pembrolizumab
40-45Gy/20fx,5 times a week
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
RECRUITINGPathological response
Postoperative pathology according to CAP classification.
Time frame: After surgery
2-year and 5-year overall survival
overall survival after 2 years and 5 years
Time frame: 2 years and 5 years after therapy
Adverse effect incidence
Adverse effect according to CTCAE and RTOG criteria
Time frame: 1 years after therapy
R0 resection rate
Time frame: After surgery
postoperative complications
postoperative complications according to Clavien-Dindo classification
Time frame: After surgery
2-year and 5-year disease-free survival
disease-free survival after 2 years and 5 years
Time frame: 2 years and 5 years after therapy
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