Envafolimab with albumin-bound paclitaxel and carboplatin before surgery 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

This study tests whether adding envafolimab to albumin-bound paclitaxel and carboplatin before surgery helps people with resectable locally advanced esophageal squamous cell carcinoma.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 26 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Shanghai Zhongshan Hospital (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy, Envafolimab
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT07266493 on ClinicalTrials.gov

What this trial studies

This single-center, prospective, single-arm Phase 2 trial gives patients with resectable locally advanced esophageal squamous cell carcinoma a course of envafolimab combined with albumin-bound paclitaxel and carboplatin as neoadjuvant therapy prior to planned surgical resection. Eligible patients (T2–4aNxM0, ECOG 0–1) who have not received prior systemic or radiation therapy will receive the combination treatment and then undergo surgery. Outcomes include measures of tumor response, pathological downstaging or pathological complete response, surgical outcomes, and treatment-related adverse events. The study is designed to characterize safety and signal efficacy in a single-arm cohort at a single center.

Who should consider this trial

Good fit: Adults (≥18) with pathologically confirmed, resectable esophageal squamous cell carcinoma staged T2–4aNxM0, ECOG 0–1, who have not received prior chemotherapy, immunotherapy, targeted therapy, or radiotherapy and are planned for neoadjuvant treatment and surgery.

Not a fit: Patients with metastatic or unresectable disease, active autoimmune disorders, prior systemic or radiation therapy, or poor performance status are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, the combination could increase tumor shrinkage and pathological complete response before surgery, potentially improving surgical outcomes and long-term survival.

How similar studies have performed: Other neoadjuvant trials combining PD-1/PD-L1 inhibitors with chemotherapy in esophageal squamous cell carcinoma have reported promising pathological response rates, but envafolimab-specific neoadjuvant data are limited.

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

Where this trial is running

Shanghai, Shanghai Municipality

• Shanghai Zhongshan Hospital — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Study coordinator: Di Ge, MD

Conditions Esophageal Squamous Cell Carcinoma; Neoadjuvant Therapy; Neoadjuvant therapy; Chemotherapy; Immunotherapy