Paclitaxel Polymeric Micelles and Cisplatin Plus Sintilimab as Neoadjuvant Therapy for Resectable Locally Advanced Esophageal Squamous Cell Carcinoma

Korábbi kezelés

• Prior radiotherapy, chemotherapy, targeted therapy, or immunotherapy
• Participation in another interventional clinical trial within 4 weeks before the first dose

Más betegség

• High risk of tracheoesophageal fistula or aortoesophageal fistula
• History of other active malignancies (except cured low-risk tumors, adequately treated non-melanoma skin cancer, or carcinoma in situ)
• Active uncontrolled hepatitis B/C infection
• Uncontrolled systemic diseases (e.g., heart failure NYHA ≥II, interstitial lung disease, active autoimmune diseases requiring systemic immunosuppression)
• Allergy to study drugs or excipients

Egyéb

• Uncontrolled third-space effusion (e.g., pleural/pericardial effusion)
• Pregnant or lactating women

• Written informed consent was signed before the implementation of any test-related procedures ;
• Age 18-75 years ;
• Esophageal squamous cell carcinoma confirmed by histopathology ;
• Resectable thoracic cT1b-2N1-3M0 or cT2-3N0M0 ;
• No anti-tumor treatment has been received ;
• ECOG PS 0-1 ;
• Expected survival ≥ 3 months ;
• At least one measurable lesion per RECIST v1.1;
• Adequate organ function (hematology, liver, kidney, coagulation, thyroid, myocardial enzymes) ;
• For women of childbearing age, a negative urine or serum pregnancy test should be performed within three days prior to the first study drug administration ( day 1 of the first cycle ). If the urine pregnancy test results cannot be confirmed as negative, a blood pregnancy test is required. Women of non-fertility age were defined as at least 1 year after menopause, or had undergone surgical sterilization or hysterectomy ;
• If there is a risk of conception, all subjects ( male or female ) are required to use contraception with an annual failure rate of less than 1 % throughout the treatment period up to 120 days after the last study drug administration ( or 180 days after the last study drug administration ).