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

November 25, 2025 updated by: Ge Di, Shanghai Zhongshan Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

26

Phase

  • Phase 2

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
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200032
        • Recruiting
        • Shanghai Zhongshan Hospital
        • 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:

  • 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

Exclusion Criteria:

  • 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
  • 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;
  • 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
  • Ascites or pleural effusion with clinical symptoms cannot be controlled with medication and require therapeutic puncture or drainage;
  • The subject is known to have a history of substance abuse, alcoholism, or drug use;
  • 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

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: Experimental: Envafolimab+Chemotherapy Group（EC Group）
Envafolimab: 150mg, subcutaneous injection, administered on days 1, 8, and 15, treated for 3 weeks, followed by a 1-week rest period; Albumin bound paclitaxel: administered on days 1, 8, and 15, 100 mg/m2, IV , treated for 3 weeks, followed by a 1-week rest period; Carboplatin: administered on days 1, AUC 5, treated for 3 weeks, followed by a 1-week rest period. All patients will receive treatment with Envafolimab combined with albumin bound paclitaxel and carboplatin for three weeks, followed by one week of rest and a 28 day treatment cycle, for a total of two cycles. Then, the tumor condition of the patients will be evaluated to determine whether surgical treatment is feasible.
Drug: Chemotherapy （Albumin bound paclitaxel and Carboplatin）
Albumin bound paclitaxel: administered on days 1, 8, and 15, 100 mg/m2, IV , treated for 3 weeks, followed by a 1-week rest period; Carboplatin: administered on days 1, AUC 5, treated for 3 weeks, followed by a 1-week rest period.
Other Names:
  • Albumin bound paclitaxel and Carboplatin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pathological complete response (pCR) rate
Time Frame: From enrollment to the end of treatment at 8 weeks
From enrollment to the end of treatment at 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
R0 resection rate
Time Frame: From enrollment to the end of treatment at 10 weeks
From enrollment to the end of treatment at 10 weeks
Major pathological response rate
Time Frame: From enrollment to the end of treatment at 8 weeks
From enrollment to the end of treatment at 8 weeks
ORR
Time Frame: From enrollment to the end of Cycle 2 (each cycle is 28 days)
Objective response rate
From enrollment to the end of Cycle 2 (each cycle is 28 days)
3y-RFS rate
Time Frame: From enrollment until the date of first documented recurrence or date of death from any cause, whichever came first, assessed up to 36 months
3-year recurrence free survival rate
From enrollment until the date of first documented recurrence or date of death from any cause, whichever came first, assessed up to 36 months
3y-OS rate
Time Frame: From enrollment until the date of death from any cause, assessed up to 36 months
3-year Overall survival rate
From enrollment until the date of death from any cause, assessed up to 36 months

Collaborators and Investigators

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

Sponsor

Shanghai Zhongshan Hospital

Collaborators

Jiangsu Simcere Pharmaceutical Co., Ltd.

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)

December 1, 2023

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

November 25, 2025

First Submitted That Met QC Criteria

November 25, 2025

First Posted (Actual)

December 5, 2025

Study Record Updates

Last Update Posted (Actual)

December 5, 2025

Last Update Submitted That Met QC Criteria

November 25, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B2023-222R

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

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