Anlotinib plus Bemocizumab as neoadjuvant therapy for ESCC
Official title: Clinical Trial on the Efficacy and Safety of Anlotinib Combined With Bemocizumab for Neoadjuvant Therapy of Resectable Esophageal Squamous Cell Carcinoma
Run by Nanfang Hospital, Southern Medical University · NCT07627347 · Data updated 2026-11-12
This trial tests whether giving anlotinib with bemocizumab before surgery can improve how completely the tumor is removed and prevent recurrence in people with resectable esophageal squamous cell carcinoma.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 70 Years |
| Sex | All |
| Enrollment | 25 (estimated) |
| Sponsor | Nanfang Hospital, Southern Medical University Academic / other |
| Drugs / interventions | anlotinib, bemocizumab, bemarituzumab |
| Locations | 1 site (Guangzhou, Guangdong) |
| Status | Recruiting |
| Started | May 18, 2026 |
| Main results expected | December 30, 2027 |
| Study ends | December 30, 2028 |
| Registry record updated | June 4, 2026 |
| Trial ID | NCT07627347 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18-70 with resectable ESCC meeting TNM II-III B criteria, ECOG 0-1, and adequate organ function, who have not received prior treatment for esophageal cancer.
✕Probably not a fit
Patients with disease progression before surgery, poor operability after neoadjuvant therapy, or lack of measurable disease may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, single-arm, single-center study evaluating the efficacy and safety of neoadjuvant anlotinib combined with bemarituzumab in resectable ESCC. Participants receive 3-4 cycles of therapy before esophagectomy, with post-surgery follow-up to assess disease-free survival. The primary aim is to improve pathological complete response and R0 resection rates, potentially translating to better outcomes after surgery. Eligibility includes adults 18-70 with specific staging criteria and good organ function. Surgical approach is standard thoracoabdominal or alternative esophagectomy as appropriate, followed by adjuvant therapy based on individual condition.
Why it matters
Potential benefit: If successful, patients may have higher rates of complete tumor removal and longer disease-free survival after surgery.
How similar studies have gone: Previous neoadjuvant approaches with targeted therapy have shown promise in some cancers, but this specific combination in ESCC is exploratory and not yet proven.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China Recruiting
Study contacts
- Principal investigator: Xuguang Rao, PhD. — Nanfang Hospital, Southern Medical University
- Study coordinator: Zhizhi Wang, MD
- Email: 347901213@qq.com
- Phone: +8616676770718
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.