This study aims to explore the efficacy and safety of anlotinib combined with bemocizumab as neoadjuvant therapy for resectable esophageal squamous cell carcinoma, with the goal of improving the pathological complete response (pCR) rate and margin-negative resection(R0) resection rate in patients undergoing esophageal cancer surgery, as well as enhancing disease-free survival (DFS) in postoperative patients. This will provide guidance and new options for the treatment of patients with locally advanced esophageal cancer.
This is a prospective, single-arm, single-center clinical study aimed at evaluating the efficacy and safety of anlotinib combined with bemarituzumab in neoadjuvant treatment for resectable esophageal squamous cell carcinoma, with the goal of improving the pathological complete response (pCR) rate and margin-negative resection(R0) resection rate in patients undergoing esophageal cancer surgery, as well as enhancing disease-free survival (DFS) in postoperative patients. The study plans to enroll 25 eligible participants who meet the inclusion and exclusion criteria. Patients will receive 3-4 cycles of neoadjuvant therapy prior to surgery, consisting of bemarituzumab at 1200 mg every 3 weeks and anlotinib at 8 mg daily from day 1 to day 14. 。 Surgical eligibility will be assessed 4-6 weeks after completion of neoadjuvant therapy. Patients achieving complete response (CR), partial response (PR), or stable disease (SD) will undergo surgery. Patients with progressive disease (PD) who are deemed operable by the investigator will also proceed to surgery; otherwise, they will be withdrawn from the study. The surgical approach will typically involve a standard three-incision thoracoabdominal laparoscopic esophagectomy, although Ivor-Lewis or Sweet procedures may also be used as appropriate. Postoperative adjuvant therapy will be administered based on individual patient conditions. Following surgery, pathological evaluation will be performed to determine the primary endpoint, pathologic complete response (pCR). Subsequent follow-up will continue for 5 years to assess other secondary endpoints.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
Received neoadjuvant therapy for 3-4 cycles before surgery, with the specific regimen as follows: bevacizumab, 1200mg q3w; anlotinib, 8mg qd d1-d14
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China
RECRUITINGPCR
The measurement method for pathological complete response rate (pCR rate) involves pathological examination after surgical resection to confirm the absence of any viable tumor cells in the primary lesion and regional lymph nodes, which is denoted as "1". If this criterion is not met, it is denoted as "0". The final calculation is based on the percentage of patients achieving pCR out of the total number of patients.
Time frame: Perioperative
OS
Overall survival time
Time frame: up to 5 years
R0 margin-negative resection rate
margin-negative resection rate
Time frame: Perioperative
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