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NCT07266493RecruitingPhase 2

Efficacy and Safety of Neoadjuvant Envafolimab Combined With Albumin-bound Paclitaxel and Carboplatin for Resectable Locally Advanced Esophageal Squamous Cell Carcinoma

A Single-arm, Open-label, Single-center Prospective Study of Neoadjuvant Envafolimab Combined With Albumin-bound Paclitaxel and Carboplatin for Resectable Locally Advanced Esophageal Squamous Cell Carcinoma

Source: ClinicalTrials.gov · Last updated 5 Dec 2025

Brief summary (registry, in English)

This single center, prospective, single arm clinical study aims to evaluate the clinical efficacy and safety of Envafolimab combined with albumin bound paclitaxel and carboplatin as neoadjuvant therapy for locally advanced esophageal squamous cell carcinoma.

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
26 (estimated)
First submitted
25 Nov 2025
Start date
1 Dec 2023
Primary completion date
1 Jun 2026
Lead sponsor
Shanghai Zhongshan Hospital
NCT number
NCT07266493

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 26
  • From 1 Dec 2023 to the primary completion date, 1 Jun 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • The subject has previous or concurrent malignant tumors;
  • Patients who have received systemic anti-tumor therapy in the past;
  • Individuals who have undergone significant surgical treatment, open biopsy, or significant traumatic injury within 28 days prior to the start of treatment; Or there may be wounds or fractures that have not been cured for a long time;
  • Ascites or pleural effusion with clinical symptoms cannot be controlled with medication and require therapeutic puncture or drainage;

Other illness

  • The subjects have any active autoimmune diseases or a history of autoimmune diseases (such as but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, pituitary inflammation, vasculitis, nephritis, thyroid dysfunction (hyperthyroidism/hypothyroidism), and the use of drugs cannot maintain thyroid function within the normal range, or patients who have undergone thyroid surgery and require long-term replacement therapy with thyroid hormone and other drugs after surgery); Subjects with vitiligo or complete remission of childhood asthma who do not require any intervention in adulthood may be included; Asthma in which subjects require bronchodilators for medical intervention cannot be included
  • There is a risk of bleeding, coagulation dysfunction, or currently undergoing thrombolytic therapy; Or have experienced esophageal or gastric variceal rupture bleeding in the past 6 months;
  • It is known that the subject has a history of allergies to large molecule protein preparations or drug ingredients used;
  • Subjects with any severe and/or uncontrolled illnesses
  • The subject is known to have a history of substance abuse, alcoholism, or drug use;

Other

  • The researchers believe that participants should be excluded from this study, for example, if the researchers determine that there are other factors that may cause the study to be terminated midway

Who the study is looking for

  • The subjects voluntarily joined this study, were able to sign the informed consent form, and had good compliance;
  • Age ≥ 18 years old (when signing the informed consent form);
  • ECOG score 0-1 points;
  • Diagnosed with operable esophageal squamous cell carcinoma through pathological diagnosis (pathological tissue/cytology) and imaging;
  • The clinical TNM staging is T2-4aNxM0
  • Patients assessed to require routine neoadjuvant therapy;
  • Have not received immunotherapy, chemotherapy, targeted therapy, or radiotherapy in the past;
  • Expected survival ≥ 12 weeks

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Shanghai Zhongshan Hospital
Coordinator of this site? Confirm its status
ShanghaiChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.