Efficacy and Safety of Anlotinib Combined With Bemocizumab for Neoadjuvant Therapy of Esophageal Squamous Cell Carcinoma(ESCC) (RAOS)

May 31, 2026 updated by: Nanfang Hospital, Southern Medical University

Clinical Trial on the Efficacy and Safety of Anlotinib Combined With Bemocizumab for Neoadjuvant Therapy of Resectable Esophageal Squamous Cell Carcinoma

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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disease (PD) who are deemed operable by the investigator will also proceed to surgery; otherwise, they will be withdrawn from the study.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

Enrollment (Estimated)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510515
        • Recruiting
        • Nanfang Hospital, Southern Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Aged 18-70, both male and female
  2. After gastroscopy/ultrasonic gastroscopy biopsy, the pathology suggests squamous cell carcinoma of the esophagus, and the clinical diagnosis is cT2N1-2M0 or cT3N0-2M0, with TNM staging of II-III B
  3. Patients with non-cervical esophageal cance
  4. The patient has not previously received systemic or local treatment for esophageal cancer, and according to the RECIST 1.1 criteria, there is at least one measurable lesion for imaging evaluation of neoadjuvant therapy
  5. ECOG PS: 0-1
  6. Expected survival duration ≥ 12 months
  7. The subjects had no functional disorders of major organs, and the researchers assessed that thyroid, lung, liver, kidney, and heart functions were basically normal;
  8. Women of childbearing age must have already taken reliable contraceptive measures or undergone a pregnancy test (serum or urine) within 7 days prior to enrollment, with a negative result, and be willing to use appropriate contraception during the trial and for 8 weeks after the last administration of the trial medication. For males, they must agree to use appropriate contraception during the trial and for 8 weeks after the last administration of the trial medication, or have undergone surgical sterilization
  9. The subjects voluntarily joined this study, signed the informed consent form, exhibited good compliance, actively cooperated with the planned schedule by returning to the hospital for regular clinical follow-ups and necessary treatments, and cooperated with the regular collection of blood and tissue samples

Exclusion Criteria:

  1. Within the past 5 years, there has been or is currently a co-occurrence of other malignant tumors, except for cured cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor invades the basement membrane)]
  2. Patients with ulcerative esophageal squamous cell carcinoma
  3. Patients with esophageal fistula or tracheal fistula;
  4. Those who are allergic to anlotinib and bemusuban
  5. Those with a history of immune deficiency, including HIV-positive or suffering from other acquired or congenital immune deficiency diseases, or those who have undergone organ transplantation
  6. Patients with any severe and/or uncontrolled diseases
  7. Unresolved toxic reactions above CTC AE Grade 1 caused by any previous treatment, excluding alopecia;
  8. Individuals with multiple factors affecting oral medication administration, such as inability to swallow, chronic diarrhea, and intestinal obstruction
  9. Urine routine test indicates proteinuria ≥++ and confirmed 24-hour urine protein quantitation > 1.0 g
  10. Subjects who underwent major surgical procedures, incisional biopsies, or significant traumatic injuries within 28 days prior to grouping
  11. Abnormal coagulation function: INR > 1.5 or prothrombin time (PT) > ULN + 4 seconds or APTT > 1.5ULN), with a tendency to bleed or undergoing thrombolytic or anticoagulant therapy; patients who have experienced any bleeding or hemorrhagic events ≥ CTCAE Grade 3 within 4 weeks before grouping, have unhealed wounds, ulcers, or fractures
  12. Those who have experienced arterial or venous thromboembolic events within 6 months, such as cerebrovascular accidents (including transient ischemic attacks), deep vein thrombosis, and pulmonary embolism
  13. Pregnant or lactating women
  14. Patients with distant metastasis
  15. Patients with significant bone marrow suppression
  16. Suffering from mental illness or having a history of abuse of psychotropic drugs;
  17. Patients who have participated in other drug clinical trials within 4 weeks;
  18. Patients with concomitant diseases that, according to the researcher's judgment, pose serious risks to patient safety or affect patients' ability to complete the study
  19. Individuals with hereditary bleeding tendency, coagulation dysfunction, potential invasion of large blood vessels, and other bleeding risks, who have experienced clinically significant bleeding symptoms or have a clear tendency to bleed within the previous 3 months before enrollment, such as gastrointestinal bleeding, bleeding gastric ulcer, and baseline fecal occult blood test result of ++ or above
  20. Researchers consider those who are not suitable for inclusion

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Anlotinib+ Bevacizumab group
Received neoadjuvant therapy for 3-4 cycles before surgery, with the specific regimen as follows: bevacizumab, 1200mg q3w; anlotinib, 8mg qd d1-d14
Drug: anlotinib+bevacizumab
Received neoadjuvant therapy for 3-4 cycles before surgery, with the specific regimen as follows: bevacizumab, 1200mg q3w; anlotinib, 8mg qd d1-d14
Other Names:
  • Neoadjuvant Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PCR
Time Frame: Perioperative
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.
Perioperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
OS
Time Frame: up to 5 years
Overall survival time
up to 5 years
R0 margin-negative resection rate
Time Frame: Perioperative
margin-negative resection rate
Perioperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanfang Hospital, Southern Medical University

Investigators

  • Principal Investigator: Xuguang Rao, PhD., Nanfang Hospital, Southern Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 18, 2026

Primary Completion (Estimated)

December 30, 2027

Study Completion (Estimated)

December 30, 2028

Study Registration Dates

First Submitted

May 20, 2026

First Submitted That Met QC Criteria

May 31, 2026

First Posted (Actual)

June 4, 2026

Study Record Updates

Last Update Posted (Actual)

June 4, 2026

Last Update Submitted That Met QC Criteria

May 31, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NFEC-2026-220

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

CSR

IPD Sharing Time Frame

Sharing within 12 months after publication

IPD Sharing Access Criteria

Follow the new regulations of the International Committee of Medical Journal Editors (ICMJE) on the sharing of raw data from clinical trials, as well as the requirements of registration platforms such as ClinicalTrials.gov. For projects involving national security or confidentiality requirements for new drug development, implement limited sharing control

IPD Sharing Supporting Information Type

  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on ESCC

Clinical Trials on anlotinib+bevacizumab

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Greece

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe