Serplulimab Combined With Nab-paclitaxel and Cisplatin in Neoadjuvant Therapy for Resectable Esophageal Squamous Cell Carcinoma
- Conditions
- Esophageal Squamous Cell Carcinoma
- Interventions
- Drug: nab-paclitaxel，Cisplatin
- Registration Number
- NCT06388135
- Lead Sponsor
- Yang Jianjun, PhD
- Brief Summary
Abstract Objective: This study aims to investigate the potential clinical impact of neoadjuvant immunotherapy in resectable esophageal squamous cell carcinoma (ESCC).
The efficacy and safety of combining the programmed death 1 (PD-1) inhibitor serplulimab with nab-paclitaxel and cisplatin as neoadjuvant therapy in patients with resectable ESCC will be evaluated. Methods and analysis: A prospective, single-center, open-label cohort study will enroll 80 patients, with 40 patients allocated to the experimental group and 40 patients to the control group. Patients in the experimental arm will undergo 3 cycles of neoadjuvant therapy comprising serplulimab, cisplatin, and nab-paclitaxel, while those in the control arm will receive 3 cycles of neoadjuvant therapy with cisplatin and nab-paclitaxel. The primary efficacy endpoint will be the assessment of pathological complete response (pCR) following neoadjuvant therapy. Secondary efficacy endpoints will include major pathological response (MPR), disease-free survival, objective response rate (ORR), and monitoring of adverse events (AEs).
Ethics: Ethics approval has been obtained from the Ethics Committee at the First Affiliated Hospital (Xijing Hospital) of Air force Military Medical University (KY20242052-C-1).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 80
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Serplulimab，nab-paclitaxel，Cisplatin Serplulimab Combined With Nab-paclitaxel and Cisplatin Serplulimab (200 mg), cisplatin (60-75 mg/m2), and nab-paclitaxel (135 mg/m2) administered intravenously at the beginning of every 3-week cycle nab-paclitaxel，Cisplatin nab-paclitaxel，Cisplatin Cisplatin (60-75 mg/m2) and nab-paclitaxel (135 mg/m2) given intravenously at the beginning of every 3-week cycle.
- Primary Outcome Measures
Name Time Method pCR after surgery,within 12 weeks pathological Complete Response
- Secondary Outcome Measures
Name Time Method ORR up to 24 months objective response rate
MPR after surgery,within 12 weeks major pathologic response
DFS up to 24 months Disease free survival
AEs up to 24 months adverse events