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Clinical Trials/NCT07549269
NCT07549269
Completed
Not Applicable

Comparison of Nab-Paclitaxel Versus Paclitaxel in Neoadjuvant Immunochemotherapy Therapy for Esophageal Squamous Cell Carcinoma: A Retrospective IPTW-Adjusted Analysis

Sichuan University1 site in 1 country387 target enrollmentStarted: December 1, 2019Last updated:

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

Sponsor
Sichuan University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Zhen-Yu Ding

professor

Sichuan University

Study Sites (1)

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