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RecruitingNCT07627347RAOSUpdated Jun 4, 2026

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

An interventional study of anlotinib+bevacizumab in ESCC, sponsored by Nanfang Hospital, Southern Medical University. Recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-06-04.

Sponsored by Nanfang Hospital, Southern Medical University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started May 2026; still recruiting 4 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Study summary

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.

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disease (PD) who are deemed operable by the investigator will also proceed to surgery; otherwise, they will be withdrawn from the study.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

02

Conditions studied

  • ESCC

Keywords

  • ESCC
  • Neoadjuvant therapy Immunotherapy
  • Chemotherapy-free
  • Anlotinib
03

In context

Lead sponsor

Nanfang Hospital, Southern Medical University is the lead sponsor of 480 studies on the registry; 212 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
25 participants (estimated)

Study arms

  • 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

Interventions

  • Druganlotinib+bevacizumab

    Received neoadjuvant therapy for 3-4 cycles before surgery, with the specific regimen as follows: bevacizumab, 1200mg q3w; anlotinib, 8mg qd d1-d14

    Also known as: Neoadjuvant Therapy

06

What researchers measure

Primary outcomes

  1. PCR

    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

Secondary outcomes

  1. OS

    Overall survival time

    Time frame: up to 5 years

  2. R0 margin-negative resection rate

    margin-negative resection rate

    Time frame: Perioperative

07

Study locations

1 of 1 sites recruiting
  • Nanfang Hospital, Southern Medical University
    Guangzhou, Guangdong 510515, China
    Recruiting
08

References and documents

Publications

  • Update results of anlotinib combined with TQB2450 (PD-L1 blockade) as first-line treatment for advanced esophageal squamous cell carcinoma (ESCC): a single-arm, multicenter, open-label phase Ⅱ clinical trial.2023 ESMO.1531P.
  • Updated results of a phase II clinical trial: paclitaxel and carboplatin plus PD-1 blockades combined with anlotinib as first-line treatment for advanced esophageal cancer.2023ESMO 1542P.
  • Xiaolin Lin, Qing Xia, Ting Han, et al. Efficacy and safety of toripalimab combination with SOX regimen as a first-line treatment in patients with unresectable locally advanced or recurrent/metastatic gastric/gastroesophageal junction cancer: Preliminary data from a single-armed, exploratory study.2022 ASCO e16015
  • Fukuoka S, Hara H, Takahashi N, Kojima T, Kawazoe A, Asayama M, Yoshii T, Kotani D, Tamura H, Mikamoto Y, Hirano N, Wakabayashi M, Nomura S, Sato A, Kuwata T, Togashi Y, Nishikawa H, Shitara K. Regorafenib Plus Nivolumab in Patients With Advanced Gastric or Colorectal Cancer: An Open-Label, Dose-Escalation, and Dose-Expansion Phase Ib Trial (REGONIVO, EPOC1603). J Clin Oncol. 2020 Jun 20;38(18):2053-2061. doi: 10.1200/JCO.19.03296. Epub 2020 Apr 28. PubMed 32343640 ↗
  • Martin Reck et al. atezolizumab (atezo) + bevacizumab (bev) and chemotherapy in first-line (1L) metastatic nonsquamous (nsq) non-small cell lung cancer (NSCLC) across key subgroups. 2022 AACR Abstract CT216
  • Shapiro J, van Lanschot JJB, Hulshof MCCM, van Hagen P, van Berge Henegouwen MI, Wijnhoven BPL, van Laarhoven HWM, Nieuwenhuijzen GAP, Hospers GAP, Bonenkamp JJ, Cuesta MA, Blaisse RJB, Busch ORC, Ten Kate FJW, Creemers GM, Punt CJA, Plukker JTM, Verheul HMW, Bilgen EJS, van Dekken H, van der Sangen MJC, Rozema T, Biermann K, Beukema JC, Piet AHM, van Rij CM, Reinders JG, Tilanus HW, Steyerberg EW, van der Gaast A; CROSS study group. Neoadjuvant chemoradiotherapy plus surgery versus surgery alone for oesophageal or junctional cancer (CROSS): long-term results of a randomised controlled trial. Lancet Oncol. 2015 Sep;16(9):1090-1098. doi: 10.1016/S1470-2045(15)00040-6. Epub 2015 Aug 5. PubMed 26254683 ↗
  • Yang H, Liu H, Chen Y, Zhu C, Fang W, Yu Z, Mao W, Xiang J, Han Y, Chen Z, Yang H, Wang J, Pang Q, Zheng X, Yang H, Li T, Lordick F, D'Journo XB, Cerfolio RJ, Korst RJ, Novoa NM, Swanson SJ, Brunelli A, Ismail M, Fernando HC, Zhang X, Li Q, Wang G, Chen B, Mao T, Kong M, Guo X, Lin T, Liu M, Fu J; AME Thoracic Surgery Collaborative Group. 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. J Clin Oncol. 2018 Sep 20;36(27):2796-2803. doi: 10.1200/JCO.2018.79.1483. Epub 2018 Aug 8. PubMed 30089078 ↗
  • Abnet CC, Arnold M, Wei WQ. Epidemiology of Esophageal Squamous Cell Carcinoma. Gastroenterology. 2018 Jan;154(2):360-373. doi: 10.1053/j.gastro.2017.08.023. Epub 2017 Aug 18. PubMed 28823862 ↗
  • Young K, Chau I. Targeted Therapies for Advanced Oesophagogastric Cancer: Recent Progress and Future Directions. Drugs. 2016 Jan;76(1):13-26. doi: 10.1007/s40265-015-0510-y. PubMed 26620367 ↗
  • Chen W, Sun K, Zheng R, Zeng H, Zhang S, Xia C, Yang Z, Li H, Zou X, He J. Cancer incidence and mortality in China, 2014. Chin J Cancer Res. 2018 Feb;30(1):1-12. doi: 10.21147/j.issn.1000-9604.2018.01.01. PubMed 29545714 ↗
  • Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12. PubMed 30207593 ↗

Individual participant data

Plan to share: Yes — CSR

Supporting information: Csr

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07627347
Lead sponsor
Nanfang Hospital, Southern Medical University
Responsible party
Sponsor
First posted
Jun 4, 2026
Start date
May 18, 2026
Primary completion
Dec 30, 2027 (estimated)
Completion
Dec 30, 2028 (estimated)
Last update
Jun 4, 2026

Study contacts

Zhizhi Wang, MD
Contact
347901213@qq.com
+8616676770718
Xuguang Rao, PhD.
principal investigator · Nanfang Hospital, Southern Medical University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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