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Recruiting NCT07266493

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

Phase II Interventional Esophageal Squamous Cell Carcinoma Neoadjuvant Therapy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Chemotherapy （Albumin bound paclitaxel and Carboplatin）.
Who it may be relevant to
Registry conditions: Esophageal Squamous Cell Carcinoma, Neoadjuvant Therapy. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Pathological complete response (pCR) rate [Time frame: From enrollment to the end of treatment at 8 weeks]
Secondary outcome measures (5)
  • R0 resection rate [Time frame: 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]
  • ORR [Time frame: 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]
  • 3y-OS rate [Time frame: From enrollment until the date of death from any cause, assessed up to 36 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Shanghai Zhongshan Hospital — Shanghai

Identifiers

NCT: NCT07266493 · B2023-222R

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗