Comparison of Nab-Paclitaxel Versus Paclitaxel in Neoadjuvant Immunochemotherapy Therapy for Esophageal Squamous Cell Carcinoma: A Retrospective IPTW-Adjusted Analysis
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Sichuan University
- Enrollment
- 387
- Locations
- 1
- Primary Endpoint
- PCR
Overview
Brief Summary
Taxane-based agents are widely used in the treatment of esophageal squamous cell carcinoma (ESCC). Among these, nab-paclitaxel (albumin-bound paclitaxel) and paclitaxel are the most commonly used. However, there is currently no definitive evidence comparing the efficacy of these two agents in the context of neoadjuvant therapy for ESCC.
Detailed Description
Study Background Esophageal cancer is a common and rapidly progressing malignancy. Surgery, radiotherapy, and chemotherapy are the main treatments. Paclitaxel is a widely used chemotherapy drug, but conventional paclitaxel requires solvents that can cause allergic reactions and other side effects.
Albumin-bound paclitaxel (Nab-Paclitaxel) is a newer formulation that uses albumin nanoparticles to deliver the drug. This design reduces the need for solvents, improves drug distribution, may enhance effectiveness, and potentially lowers some side effects.
Study Purpose The study aimed to compare the effectiveness and safety of Nab-Paclitaxel versus standard Paclitaxel in neoadjuvant treatment of esophageal cancer, helping clinicians choose the most suitable regimen while providing patients with understandable treatment information.
Study Design Patient population: Patients receiving neoadjuvant chemotherapy for esophageal cancer
Treatment groups:
Nab-Paclitaxel + platinum-based chemotherapy Standard Paclitaxel + platinum-based chemotherapy
Study type: Retrospective analysis (examining completed patient data)
Key outcomes evaluated: Pathological response (TRS / PCR): Tumor shrinkage before surgery Surgical outcomes: e.g., R0 resection rate, Safety and side effects
Inclusion criteria: Pathologically confirmed ESCC, baseline assessment indicating resectable or potentially resectable disease, and receipt of at least one cycle of dual-agent chemotherapy (taxane + platinum) combined with immunotherapy (PD-1 or PD-L1 inhibitor).
Exclusion criteria: Presence of other untreated malignancies, receipt of other neoadjuvant treatments (such as chemotherapy alone, neoadjuvant chemoradiotherapy, or combined chemoradiotherapy-immunotherapy regimens), incomplete data, or unwillingness to participate in follow-up.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients of any age with a histologically confirmed diagnosis of ESCC who were considered resectable or potentially resectable based on baseline assessment were eligible.
Exclusion Criteria
- •Any untreated malignancy within the past five years (except fully treated cervical carcinoma in situ or basal/squamous cell skin cancer), receipt of other neoadjuvant treatments (chemotherapy, chemoradiotherapy, or chemoradiotherapy combined with immunotherapy), incomplete medical records, or refusal to participate in follow-up.
Outcomes
Primary Outcomes
PCR
Time Frame: Within 4 weeks after surgery
Pathological Complete Response
DFS
Time Frame: From surgery to tumor progression or death
disease-free survival
Secondary Outcomes
No secondary outcomes reported
Investigators
Zhen-Yu Ding
professor
Sichuan University