Esophageal Squamous Cell Carcinoma
Conditions
Keywords
Esophageal squamous cell carcinoma, Locally advanced resectable, Paclitaxel Polymeric Micelles
Brief summary
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.
Interventions
DRUGPaclitaxel polymer micelles for injection and cisplatin combined with sintilimab
1. Sindilimab : 200 mg, Q3W, intravenous infusion, D1 ; 2. Paclitaxel polymeric micelles : 300 mg/m2 ; q3W, intravenous infusion, D1 ; 3. Cisplatin : 75 mg/m2 ; q3W ; intravenous infusion, D1 ;
Sponsors
Hebei Medical University Fourth Hospital
Shanghai Yizhong Pharmaceutical Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pathological Complete Response (pCR) rate | Assessed via surgical pathology (4-6 weeks post-neoadjuvant therapy) | Pathological Complete Response (pCR) rate: Proportion of patients with no residual invasive tumor in primary tumor bed and sampled lymph nodes (ypT0/Tis ypN0) after neoadjuvant therapy |
Secondary
| Measure | Time frame |
|---|---|
| Major Pathological Response (MPR) rate | Perioperative |
| R0 resection rate | Perioperative |
| Objective Response Rate (ORR) per RECIST v1.1 | Assessed at baseline and pre-surgery |
| Event-Free Survival (EFS) | Follow-up every 3 months for 2 years, then every 6 months up to 5 years |
| Overall Survival (OS) | Follow-up every 3 months for 2 years, then every 6 months up to 5 years |
| Safety: Incidence of adverse events (AEs), serious AEs (SAEs), and immune-related AEs (irAEs) | From initiation of treatment to 30 days post-last dose (or 90 days for SAEs) |
Countries
China
Contacts
CONTACTZiqiang Tian
Outcome results
None listed