Actively Recruiting
Clinical Trial on the Efficacy and Safety of Anlotinib Combined With Bemocizumab for Neoadjuvant Therapy of Resectable Esophageal Squamous Cell Carcinoma
Led by Nanfang Hospital, Southern Medical University · Updated on 2026-06-04
25
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
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 patient's 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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 70 years, any gender
- Diagnosed with esophageal squamous cell carcinoma confirmed by biopsy
- Clinical staging cT2N1-2M0 or cT3N0-2M0 (stage II-III B)
- No prior systemic or local treatment for esophageal cancer
- At least one measurable lesion for imaging evaluation
- ECOG performance status 0-1
- Expected survival of 12 months or more
- Normal function of major organs including thyroid, lung, liver, kidney, and heart
- Women of childbearing age must use reliable contraception and have a negative pregnancy test before enrollment
- Men must agree to use contraception during and for 8 weeks after treatment
- Willingness to provide informed consent, comply with study procedures, and attend regular follow-ups
You will not qualify if you...
- History of other malignancies in the past 5 years except certain cured non-invasive cancers
- Presence of ulcerative esophageal squamous cell carcinoma
- Esophageal or tracheal fistula
- Allergy to anlotinib or bemocizumab
- Immune deficiency or organ transplantation history
- Severe or uncontrolled diseases
- Unresolved toxic reactions from previous treatments above grade 1 (except hair loss)
- Conditions affecting oral medication intake
- Significant proteinuria or abnormal coagulation
- Major surgery or trauma within 28 days prior
- Recent bleeding or thromboembolic events
- Pregnancy or breastfeeding
- Distant metastasis
- Significant bone marrow suppression
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
Duration - 4 to 6 weeks
Participants undergo esophageal cancer surgery followed by immediate post-operative care.
1 surgery visit and multiple post-operative visits
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
Trial Site Locations
Total: 1 location
1
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China, 510515
Actively Recruiting
Research Team
Z
Zhizhi Wang, MD
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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