This clinical trial aims to preliminarily evaluate the efficacy and safety of adebrelimab combined with albumin-bound paclitaxel and carboplatin as neoadjuvant therapy for borderline resectable locally advanced esophageal squamous cell carcinoma (ESCC). The primary research objectives are to increase the R0 resection rate in such patients, thereby reducing the recurrence rate and improving overall survival (OS), as well as avoiding adverse reactions associated with radiotherapy.
Study participants shall complete the informed consent process and undergo multidisciplinary team (MDT) review for esophageal cancer. Patients confirmed as having borderline resectable disease and meeting all inclusion/exclusion criteria will be enrolled and receive treatment with adebrelimab plus albumin-bound paclitaxel and carboplatin. The treatment regimen is administered in 3-week cycles. Efficacy evaluation will be performed after 2 cycles: If the disease converts to resectable status, radical surgery will be conducted. If the disease is assessed as unresectable (progressive disease \[PD\] / stable disease \[SD\]), patients will receive definitive chemoradiotherapy or first-line treatment for advanced disease. If partial tumor regression is observed but the tumor remains unresectable, a third treatment cycle will be administered, followed by another efficacy evaluation. If the disease becomes resectable after the third cycle, radical surgery will be performed; if still unresectable (PD/SD), definitive chemoradiotherapy or first-line treatment for advanced disease will be given. For patients who achieve R0 resection, the investigator will determine the necessity of adjuvant therapy based on individual patient conditions. Patients with R1/R2 resection will receive concurrent chemoradiotherapy. If the MDT determines that radical resection is not feasible, patients will receive definitive concurrent chemoradiotherapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
42
Study participants shall complete the informed consent process and undergo multidisciplinary team (MDT) review for esophageal cancer. Patients confirmed as having borderline resectable disease and meeting all inclusion/exclusion criteria will be enrolled and receive treatment with adebrelimab plus albumin-bound paclitaxel and carboplatin.The treatment regimen is administered in 3-week cycles. Efficacy evaluation will be performed after 2 cycles.
No. 651 Dongfeng East Road, Guangzhou
Guangzhou, Guangdong, China
RECRUITINGR0 resection rate
The proportion of patients with tumor margins showing no residual cancer cells under the microscope after surgical resection. That is, the proportion of patients in PPS achieving R0 resection.
Time frame: From patient enrollment to two weeks post-surgery
Overall survival
OS is the time interval from the start of treatment to death due to any reason or loss of follow-up
Time frame: up to 5 years post-surgery
Progression free survival
Disease free survival (DFS) refers to the time from the start of treatment until disease recurrence or death from any cause, whichever occurs first.
Time frame: up to 5 years post-surgery
Pathologic complete response rate
Time frame: From patient enrollment to two weeks post-surgery
Incidence of perioperative complications
Time frame: from the first drug administration to within 30 days after the last intended treatment
Tumor Regression Grade
Time frame: From patient enrollment to two weeks post-surgery
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