Cervical Esophageal Squamous Cell Carcinoma
Conditions
Interventions
Trial group:Serplulimab: Intravenous injection, fixed dose of 300 mg, intravenous injection, Day 1, repeated every 3 weeks
Albumin-bound paclitaxel: 130 mg/m^2 on Day 1 and Day 8, repeated every 3 weeks
Carboplatin: AUC=5. Administered once every 3 weeks (single dose Not More Than 750 mg).
Sponsors
Zhejiang Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age: >=18 and =3 months; 12. Normal major organ function, no severe dysfunction of blood, heart, lungs, liver, kidneys, bone marrow, or immune deficiency diseases. Laboratory test requirements: (1) Hemoglobin (Hb) >=90 g/L; (2) White blood cells (WBC) >=3.0 × 10^9/L; neutrophil count (NEUT) >=1.5 × 10^9/L; (3) Platelet count (PLT) >=100 × 10^9/L; (4) Serum creatinine (SCr) =50 ml/min (Cockcroft-Gault formula); (5) Total bilirubin (TBIL) =2+, then 24-hour urine protein quantification must be 60%, FEV1 >1.2 L, FEV1% >40%, DLCO >40%) with tolerability for esophagectomy; 15. Women of childbearing potential must undergo a blood pregnancy test within 3 days prior to enrollment, with a negative result, and voluntarily adopt appropriate contraception methods during the observation period and for 120 days after the last administration of the investigational product; for men, they must either have undergone surgical sterilization or agree to adopt appropriate contraception methods during the observation period and for 120 days after the last administration of the investigational product; 16. Subjects voluntarily participate in this study and sign the informed consent form (ICF); 17. Subjects with expected good compliance who can follow the protocol requirements for follow-up of efficacy and adverse reactions.
Exclusion criteria
Exclusion criteria: 1. Patients pathologically confirmed as non-squamous cell carcinoma or mixed tumors 2. Esophageal cancer lesions located only in the thoracic or abdominal segments 3. Patients with recurrence or distant metastasis 4. Local lesions previously treated with local excision (including surgery/radiotherapy); Patients who previously underwent ESD/EMR (endoscopic submucosal dissection/resection) surgery are excluded 5. Patients who previously received systemic antitumor treatment 6. Patients who received treatment targeting PD-1 or PD-L1 7. Patients with active autoimmune diseases or a history of autoimmune diseases that may relapse 8. Patients with any active malignancy within 150mmHg and/or diastolic blood pressure >90mmHg) or clinically significant (e.g., active) cardiovascular diseases such as cerebrovascular accident (=500 IU/mL, or active hepatitis C virus (HCV) carriers should be excluded. Note: Non-active hepatitis B surface antigen (HBsAg) carriers, treated and stabilized hepatitis B patients (HBV DNA 38.5°C during screening/within 4 weeks before th
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate;Complete response (CR) rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Assess the cumulative time-to-total-laryngectomy-free rate in the entire cohort.;R0 resection rate in the surgical group (jointly assessed by clinical and pathology teams).;Assess progression-free survival (PFS) and overall survival (OS) in patients with resectable cervical esophageal squamous cell carcinoma following treatment with serplulimab plus chemotherapy.; | — |
Countries
China
Contacts
Public ContactWang Changchun
Zhejiang Cancer Hospital
Outcome results
None listed