This study used an open single center study design to observe the efficacy and safety of Penpulimab combined with Chemoradiotherapy(CRT) in preoperative T2,3,4aN0-1-2M0 esophageal squamous cell carcinoma (ESCC).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
66
1. Penpulimab: 200mg, intravenous infusion, once every two weeks. After completing two courses of CRT, continue to send Penpulimab 200mg every two weeks on the first and 14th days after the completion of CRT, two courses of treatment, a total of four courses. 2. Radiotherapy 40gy/20fx, once a day from Monday to Friday, completed in 4 weeks; 3. PC regimen: Paclitaxel 50mg/m2, intravenous drip, carboplatin AUC=2mg/ml/min, intravenous drip, once a week during radiotherapy, a total of 4 courses, the specific time is D1, 8, 15, 22 days after the beginning of radiotherapy. 4. Gastrointestinal reactions such as nausea and vomiting should be routinely prevented before chemotherapy. Dexamethasone 10mg should be used 30 \~ 60 minutes before paclitaxel, and intramuscular injection should be stopped immediately in case of drug or infusion reactions.
Zhongshan Hospital
Shanghai, Shanghai Municipality, China
pathological complete remission(pCR)rate
Proportion of subjects who achieved pathological complete remission (PCR),PCR was defined as the microscopic absence of tumor cells in the pathological evaluation of excised esophageal cancer lesions and regional lymph node samples after surgery.
Time frame: 3 to 4 months
safety(AE or SAE)
Incidence of adverse events or serious adverse events
Time frame: 2 to 3 years from baseline
Tumor regression grade(TRG)
Evaluation of the focus of primary tumor after radiotherapy and chemotherapy
Time frame: 3 to 4 months
R0 resection rate
Proportion of subjects reaching R0 resection. resection was defined as no tumor cells remained within 1mm of the two cutting edges of the esophageal cancer lesions removed during the operation.
Time frame: 3 to 4 months
Event free survival(EFS)
Date of first administration to date of first recording of relevant events
Time frame: 2 to 3 years from baseline
Overall survival(OS)
Date of first administration to date of death due to any cause
Time frame: 2 to 3 years from baseline
Disease free survival(DFS)
Date from the operation to the first recording of relevant events
Time frame: 2 to 3 years from baseline
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