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

ConditionESCC
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorNanfang Hospital, Southern Medical University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 18-70, both male and female

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

Patients with non-cervical esophageal cance

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

Disqualifiers

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)]

Patients with ulcerative esophageal squamous cell carcinoma

Patients with esophageal fistula or tracheal fistula;

Those who are allergic to anlotinib and bemusuban

Trial design

Design model

Single group

Treatments tested in this trial

  • anlotinib+bevacizumab

    Drug

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

Treatment groups

25 Participants
are divided into 1 treatment group
Group A: Anlotinib+ Bevacizumab groupExperimental treatment 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

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