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

Paclitaxel Polymeric Micelles and Cisplatin Plus Sintilimab as Neoadjuvant Therapy for Resectable Locally Advanced Esophageal Squamous Cell Carcinoma: A Single-arm, Multicenter, Prospective Phase II Clinical Trial

Locally advanced Esophageal Squamous Cell Carcinoma (ESCC) has poor prognosis with standard therapies. Neoadjuvant immunochemotherapy improves pathological response rates, but optimal regimens remain undefined. Paclitaxel polymeric micelles offer enhanced tumor targeting (EPR effect) and reduced toxicity vs. conventional paclitaxel formulations, with no need for premedication. This single-arm, prospective trial evaluates the efficacy and safety of neoadjuvant sintilimab combined with paclitaxel polymeric micelles and cisplatin in resectable locally advanced ESCC.

Inclusion Criteria:

1. Written informed consent was signed before the implementation of any test-related procedures ;
2. Age 18-75 years ;
3. Esophageal squamous cell carcinoma confirmed by histopathology ;
4. Resectable thoracic cT1b-2N1-3M0 or cT2-3N0M0 ;
5. No anti-tumor treatment has been received ;
6. ECOG PS 0-1 ;
7. Expected survival ≥ 3 months ;
8. At least one measurable lesion per RECIST v1.1;
9. Adequate organ function (hematology, liver, kidney, coagulation, thyroid, myocardial enzymes) ;
10. 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 ;
11. 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 ).

Exclusion Criteria:

1. High risk of tracheoesophageal fistula or aortoesophageal fistula
2. Prior radiotherapy, chemotherapy, targeted therapy, or immunotherapy
3. Participation in another interventional clinical trial within 4 weeks before the first dose
4. History of other active malignancies (except cured low-risk tumors, adequately treated non-melanoma skin cancer, or carcinoma in situ)
5. Active uncontrolled hepatitis B/C infection
6. Uncontrolled systemic diseases (e.g., heart failure NYHA ≥II, interstitial lung disease, active autoimmune diseases requiring systemic immunosuppression)
7. Allergy to study drugs or excipients
8. Uncontrolled third-space effusion (e.g., pleural/pericardial effusion)
9. Pregnant or lactating women