Study of Anlotinib and Bemocizumab as Pre-Surgery Treatment for Resectable Esophageal Squamous Cell Carcinoma to Improve Surgery Outcomes and Disease-Free Survival
Led by Nanfang Hospital, Southern Medical University · Updated on 2026-06-04
25
Participants Needed
1
Research Sites
52 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of anlotinib combined with bemocizumab as a neoadjuvant therapy for patients with resectable esophageal squamous cell carcinoma ESCC. The goal is to improve the rates of complete pathological response and margin-negative resection in patients undergoing surgery, and to enhance disease-free survival after surgery. This prospective, single-arm clinical study will provide new treatment options and guidance for locally advanced esophageal cancer.
Participants will receive 3 to 4 cycles of neoadjuvant therapy before surgery, consisting of bemocizumab at 1200 mg every 3 weeks and anlotinib at 8 mg daily for 14 days per cycle. Surgery will be scheduled 4 to 6 weeks after completing the neoadjuvant therapy, and will typically involve a three-incision thoracoabdominal laparoscopic esophagectomy, with other surgical approaches used as appropriate. Postoperative adjuvant therapy will be given based on each patients condition.
During the study, participants will undergo pathological evaluation after surgery to determine the primary outcome of pathological complete response. Follow-up will continue for 5 years to assess outcomes such as overall survival and margin-negative resection rates. Patients will attend regular clinical visits for assessments, blood and tissue sample collection, and monitoring of safety and disease status throughout the study period.
CONDITIONS
Brief Title
Efficacy and Safety of Anlotinib Combined With Bemocizumab for Neoadjuvant Therapy of Esophageal Squamous Cell Carcinoma(ESCC)
Research Team
Z
Zhizhi Wang, MD
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Mental illness or history of psychotropic drug abuse
Recent participation in other drug trials
Any condition posing serious risk or affecting study completion
Hereditary bleeding disorders or recent significant bleeding
Investigator's judgment of unsuitability for the study
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Approximately 9 to 12 weeks
Participants receive 3 to 4 cycles of neoadjuvant therapy with bemarituzumab and anlotinib before surgery.
Cycles every 3 weeks with daily medication for 14 days per cycle
Surgery and Immediate Post-operative Care
Duration - 4 to 6 weeks
Participants undergo esophageal cancer surgery followed by immediate post-operative care.
1 surgery visit and multiple post-operative visits
Follow-up
Duration - Up to 5 years
Participants are followed for up to 5 years to assess long-term outcomes and disease-free survival.
Regular follow-up visits over 5 years
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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Published Research Related To This Trial
Neoadjuvant chemoradiotherapy plus surgery versus surgery alone for oesophageal or junctional cancer (CROSS): long-term results of a randomised controlled trial.
Joel Shapiro, J Jan B van Lanschot, Maarten C C M Hulshof...
Neoadjuvant Chemoradiotherapy Followed by Surgery Versus Surgery Alone for Locally Advanced Squamous Cell Carcinoma of the Esophagus (NEOCRTEC5010): A Phase III Multicenter, Randomized, Open-Label Clinical Trial.
Regorafenib Plus Nivolumab in Patients With Advanced Gastric or Colorectal Cancer: An Open-Label, Dose-Escalation, and Dose-Expansion Phase Ib Trial (REGONIVO, EPOC1603).