Efficacy and Safety of Neoadjuvant Envafolimab Combined With Albumin-bound Paclitaxel and Carbopl… (NCT07266493) | Clinical Trial Compass
RecruitingPhase 2
Efficacy and Safety of Neoadjuvant Envafolimab Combined With Albumin-bound Paclitaxel and Carboplatin for Resectable Locally Advanced Esophageal Squamous Cell Carcinoma
China26 participantsStarted 2023-12-01
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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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 …
What they're measuring
1
Pathological complete response (pCR) rate
Timeframe: From enrollment to the end of treatment at 8 weeks