Envafolimab with albumin-bound paclitaxel and carboplatin before surgery for resectable locally advanced esophageal squamous cell carcinoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Shanghai Zhongshan Hospital
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Di Ge, MD
• Email: gedi@zs-hospital.sh.cn
• Phone: 86-18202188606

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Camrelizumab, chemotherapy and Ivarmacitinib before surgery for resectable esophageal squamous cell carcinoma

  This trial tests whether giving camrelizumab with chemotherapy and the JAK inhibitor Ivarmacitinib before surgery can improve outcomes for patients with locally advanced esophageal squamous cell carcinoma that can be removed by operation.

  Recruiting Phase 2 Second Affiliated Hospital, Zhejiang University, School of Medicine · Hangzhou, China · NCT07505186

• Ivonescimab plus chemotherapy before surgery for resectable esophageal squamous cell cancer

  This study tests whether giving Ivonescimab together with chemotherapy before esophageal cancer surgery helps patients see better outcomes than surgery alone.

  Recruiting Phase 2 Second Affiliated Hospital, Zhejiang University, School of Medicine · Hangzhou, Zhejiang · NCT07244978

• Neoadjuvant therapy for locally advanced esophageal squamous cell carcinoma

  This study is testing two different treatment plans for people with advanced esophageal cancer to see which one works better and is safer before surgery.

  Recruiting Phase 2/3 Army Medical Center of PLA · Chongqing, None Selected · NCT06354530

• MRD-guided postoperative monitoring and adaptive treatment for resectable NSCLC

  This study tests a personalized follow-up and treatment plan using ctDNA MRD testing and pathology to guide adjuvant therapy after surgery for stage IB-IIIA NSCLC treated with neoadjuvant immunotherapy.

  Recruiting Peking University People's Hospital · Beijing, Beijing Municipality · NCT07894458

• Radiotherapy target-volume choices in locally advanced esophageal cancer during immunotherapy

  This observational study looks at how doctors outline the radiation area for locally advanced esophageal squamous cell cancer patients treated with radiotherapy and immunotherapy to see which approaches correlate with better outcomes.

  Recruiting Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Beijing, Beijing Municipality · NCT07858630

• Perioperative therapy with Retlirafusp alfa, Famitinib, and HAIC-GEMOX for locally advanced intrahepatic cholangiocarcinoma

  This trial tests whether a perioperative treatment combo (Retlirafusp alfa, famitinib, and HAIC-GEMOX) can help shrink or control locally advanced intrahepatic cholangiocarcinoma before surgery and support additional therapy afterward in adults.

  Recruiting Phase 2 The First Affiliated Hospital with Nanjing Medical University · Nanjing, Jiangsu · NCT07847710

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.